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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 29  |  Issue : 3  |  Page : 530-538

The effects of using pregabalin versus clonidine premedication in laparoscopic cholecystectomy


1 Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Medical Biochemistry, Faculty of Medicine, Menoufia University, Menoufia, Egypt

Date of Submission25-Nov-2014
Date of Acceptance12-Jan-2015
Date of Web Publication23-Jan-2017

Correspondence Address:
Nadia M Bahgat
Department of Anesthesia and Intensive Care, Faculty of Medicine, Menoufia University, Menoufia, 32511
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1110-2098.198695

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  Abstract 

Objectives
The aim of this study was primarily to compare the efficacy of oral premedication with pregabalin versus clonidine on stress response and hemodynamic stability during laryngoscopy in adult patients undergoing elective laparoscopic cholecystectomies, and, second, to evaluate sedation, anxiety, and postoperative analgesic effects of both oral premedications.
Background
Laparoscopic cholecystectomy induces hemodynamic responses, which should be attenuated with appropriate premedication. Moreover, after laparoscopic cholecystectomy, patients report visceral pain and shoulder tip pain resulting from diaphragmatic irritation, which should be relieved with appropriate analgesics.
Patients and methods
Sixty adult patients aged 18-60 years with American Society of Anesthesiologist physical status I of both sexes scheduled for elective laparoscopic cholecystectomy were randomized to receive pregabalin 300 mg (group P), clonidine 200 μg (group C), or placebo (group O), given 90 min before surgery as oral premedication. Anesthetic technique was standardized and all groups were assessed for preoperative sedation level using the Ramsay Sedation Scale, along with changes in heart rate and mean arterial pressure, before premedication, before induction, after laryngoscopy, after creation of pneumoperitoneum, and after extubation. Intraoperative propofol, isoflurane, and opioid drug requirement and postoperative complications were recorded.
Results
Perioperative sedation levels were higher with pregabalin than with clonidine, without prolongation of recovery time. Statistically significant attenuation of mean arterial pressure and heart rate to laryngoscopy and laparoscopy was observed in the premedicated groups. The visual analogue scale scores of both the pregabalin and the clonidine group were significantly lower than that in the control group at 1, 4, and 8 h after surgery.
Conclusion
This study confirms that oral premedication with pregabalin 300 mg or clonidine 200 μg produces sedation and hemodynamic stability during laparoscopic cholecystectomy and a decrease in postoperative pain and analgesic consumption.

Keywords: cholecystectomy, clonidine, laparoscopic, pregabalin, premedication


How to cite this article:
Bahgat NM, Sadik SA, Mahdy WR, El-Sharkawy OA, Metwally AA, El-Shafey MK. The effects of using pregabalin versus clonidine premedication in laparoscopic cholecystectomy. Menoufia Med J 2016;29:530-8

How to cite this URL:
Bahgat NM, Sadik SA, Mahdy WR, El-Sharkawy OA, Metwally AA, El-Shafey MK. The effects of using pregabalin versus clonidine premedication in laparoscopic cholecystectomy. Menoufia Med J [serial online] 2016 [cited 2020 Jun 3];29:530-8. Available from: http://www.mmj.eg.net/text.asp?2016/29/3/530/198695


  Introduction Top


The hallmark of laparoscopy is the creation of pneumoperitoneum and change in the patient position using Trendelenburg or reverse Trendelenburg position [1] . Further, laparoscopy results in stress hormone responses (cortisol, epinephrine, and norepinephrine), especially with CO 2 pneumoperitoneum [2] .

Hemodynamic responses of laryngoscopy and laparoscopy should be attenuated with appropriate premedication, smooth induction, and rapid intubation [3] . Moreover, after laparoscopic cholecystectomy, patients report visceral pain and shoulder tip pain resulting from diaphragmatic irritation. Postoperative neck and shoulder pain is reported by 80% of patients at 2-4 h and by 50% at 48 h [4] .

Many pharmacological methods were evaluated either during premedication or during induction of anesthesia to attenuate the adverse hemodynamic response to laryngoscopy and laparoscopy, such as deepening the level of anesthesia, pretreatment with vasodilators, adrenoreceptor blockers, calcium channel blocker, and opioids, with variable results [3] .

The present study aimed at evaluating the clinical efficacy of oral premedication with pregabalin or clonidine on hemodynamic stability during laryngoscopy and laparoscopy and evaluating the effect of these oral premedicants on postoperative analgesia in patients undergoing laparoscopic cholecystectomy.


  Patients and methods Top


This prospective randomized study was conducted on 60 patients of American Society of Anesthesiologist physical status I scheduled for elective laparoscopic cholecystectomy under general anesthesia after approval from the Medical Ethics Committee of Menoufia University Hospital and obtaining informed consent from each patient. Patients were excluded from the study if they had difficult intubation, morbid obesity, cardiac, pulmonary, or renal diseases, drug allergy, a history of taking or were currently receiving sedative hypnotics, antidepressant drugs, or analgesics, or were anticipated to have difficult intubation. All patients who attended the hospital during the period of 2012-2013 and met the inclusion criteria were included; this rendered 60 patients as sample size. The sample size was divided equally into three groups. The patients were randomly divided using a closed envelope randomization into one of the three groups according to the oral premedication drug. Group P (20 patients) received pregabalin 300 mg (pregabalin 300 mg, Kemirica;  Chemipharm, Egypt) oral capsule. Group C (20 patients) received clonidine 200 μg (clonidine 200 μg, Catapresan; Boehringer Ingelheim, am Rhein, Germany) oral tablet. Group O (20 patients) received oral placebo drug. The oral premedication drug was given 90 min before induction of general anesthesia.

Routine monitors were attached to all patients in the operating theater. An 18 G cannula was inserted. A crystalloid intravenous infusion of 6-8 ml/kg/h was started. Anesthesia was induced with fentanyl (1 μg/kg), intravenous, followed by propofol titration, using the regimen used by Turkistani et al. [5] , in which propofol was administered in 10 mg boluses over 5 s every 15 s until the bispectral index (BIS) value reached 60 where the total dose of propofol required to achieve this value was recorded. Thereafter, atracurium 0.5 mg/kg was given to facilitate laryngoscopy and intubation. Anesthesia was maintained with minimum alveolar concentration of 1.2% isoflurane in oxygen 100%. Mechanical ventilation was started with a respiratory rate of 12/min and a tidal volume of 5-7 ml/kg and adjusted to keep the end-tidal carbon dioxide at 30-35 mmHg. Isoflurane concentration was titrated by 0.5 volume% every 5 min to allow the BIS value to range between 40 and 50. Because isoflurane titrated using BIS alone might provide hypnosis but insufficient analgesia, the protocol allowed to increase the inspired isoflurane concentration if BIS exceeded 50 (maximum allowable increase of isoflurane was 2% for 5 min); if this did not achieve the targeted values of blood pressure and heart rate, analgesia in the form of 0.5 μg/kg boluses of fentanyl were used as required.

Intravenous fentanyl (0.5 μg/kg) was also given when signs of inadequate analgesia (>20% increase in the heart rate or mean arterial blood pressure from the baseline) were observed. Hypotension (decreased systolic blood pressure below 90 mmHg or decreased mean blood pressure more than 20% from baseline measurement) was treated with (0.07-0.1 mg/kg) increment doses of intravenous ephedrine. Bradycardia, defined as heart rate slower than 50 beats/min, was treated with 0.5 mg, intravenous, atropine and repeated as necessary but not exceeding the dose of 3 mg.

Isoflurane was discontinued after the last skin suture and residual neuromuscular block was antagonized with appropriate doses of neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg). The extubation was performed after satisfactory recovery.

Each patient's vital parameters, including heart rate, mean systemic arterial blood pressure, and arterial oxygen saturation, were measured and recorded.  The Ramsay Sedation Scale was assessed at baseline (before the premedication), before induction of anesthesia, and at recovery (5 min after extubation). (Awake levels were as follows: 1 = anxious, agitated; 2 = oriented, co-operative, tranquil; and 3 = responds to command; asleep levels were dependent on patients response to a light glabellar tap or loud auditory stimulus: 4 = brisk response; 5 = sluggish response; and 6 = no response.) Intraoperative opioids and propofol consumption was reported. End-tidal isoflurane concentrations at BIS value 40-50 were measured and recorded during procedure. Incidence of intraoperative complications such as hypotension/hypertension and tachycardia/bradycardia were reported, and blood samples for measuring epinephrine and norepinephrine as stress hormones were collected on arrival to operation theater and immediately after intubation. Adrenaline and noradrenaline enzyme immunoassay test (CAT ELISA Fast Track Kit; Labor Diagnostika Nord GmbH and Co. KG, Nordhorn, Germany) was used for hormonal measurements.

Patients were transferred to the postanesthesia care unit (PACU) and monitored for severity of postoperative pain. Pain was assessed both at rest (static) and during coughing (dynamic) using a 10 mm visual analogue scale (VAS): 0, no pain, to 10, worst imaginable pain. This was carried out 5 min after arrival to the PACU (0 s time) and then every 2 h until the end of study - that is, 24 h postoperatively. From these data, the VAS at different time intervals (0, 0-4, 4-8, 8-12, and 12-24 h) for each patient was considered for statistical analysis.

If postoperative VAS was greater than 4, rescue analgesia was given in the form of ketorolac 30 mg slow, intravenous, over 30 min 12 hourly. If after 30 min the VAS was still greater than 4, increments of 0.5 mg/kg pethidine, intravenous, was given every 30 min until VAS was less than 4. Rescue antiemetic ondansetron 4 mg, intravenous, was given to all patients with postoperative nausea and vomiting.

Statistical analysis

Statistical analysis was performed on a personal computer using SPSS, version 16.0 (SPSS Inc. Chicago, US). Data were presented as mean ± SD or number (percentage). To compare mean values between the three groups, one-way analysis of variance and post-hoc Tukey's were used. Variations within groups were analyzed using the paired-samples t-test. The χ2 -test was used for comparison of proportions and frequencies among groups. A value of P less than 0.05 was considered statistically significant. A value of P less than 0.01 was considered highly statistically significant.


  Results Top


The three groups were comparable with respect to age, sex, weight, recovery time, and duration of surgery ([Table 1]).{Table 1}

A significant increase in sedation scale without respiratory depression was observed in both premedicated groups as compared with baseline sedation level and the control group. Preoperative anxiolysis and sedation were higher in the oral pregabalin group (group P) compared with the oral clonidine group (group C), but the difference was statistically nonsignificant, as shown in [Figure 1]. A statistically significant decrease in the mean arterial pressure was noticed and maintained stable within 20% of baseline value at all time points in premedicated groups. However, it was higher in the control group at all time points and the maximum rise in mean arterial pressure was noted at 1 min after intubation (P < 0.01) ([Figure 2]).
Figure 1: Preoperative and postoperative mean Ramsay Sedation Scale (MRSS).

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Figure 2: Preoperative and intraoperative mean arterial pressure changes. MAP, mean arterial pressure.

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A statistically significant decrease in the heart rate was noticed and maintained acceptable and stable at all time points in premedicated groups. However, it was higher in the control group at all time points and the maximum rise in heart rate was noted at 1 min after intubation. Comparison between group P versus group C was statistically nonsignificant at all time points; however, the difference between group P versus group O and group C versus group O was highly statistically significant (P < 0.01) ([Figure 3]).
Figure 3: Preoperative and intraoperative heart rate (HR).

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Plasma epinephrine and norepinephrine concentrations in premedicated groups were significantly lower compared with the control group before induction and after laryngoscopy ([Figure 4] and [Figure 5]).
Figure 4: Mean epinephrine level (EL) before induction and after intubation.

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Figure 5: Mean norepinephrine level (NEL) before induction and after intubation.

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Intraoperative fentanyl consumption and mean propofol requirement until the BIS level dropped below 60 during induction were significantly lower in group P and group C than in group O ([Figure 6]).
Figure 6: Induction dose of propofol and total intraoperative fentanyl consumption.

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[Figure 7] shows that the intraoperative reading of BIS in the three studied groups was maintained between 40 and 50.
Figure 7: Mean bispectral index values (BIS).

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The end-tidal isoflurane concentrations to maintain the BIS value between 40 and 50 were significantly lower in group P and group C compared with group O at all measurement times ([Figure 8]).
Figure 8: End-tidal isoflurane concentration for maintenance of anesthesia. TE, end tidal

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The incidence of hypertension in the control group was 35% (seven patients) and the incidence of tachycardia was 40% (eight patients), which were highly statistically significant in comparison with premedicated groups. Besides, hypotension was recorded in four patients in the clonidine group (group C) and in two patients in the pregabalin group, with no statistically significant differences among groups. The incidence of intraoperative bradycardia was 15% (three patients) in the clonidine group, whereas there was no incidence of bradycardia in group P and group C. The difference was statistically significant ([Table 2]).{Table 2}

There was no nausea or vomiting observed in any patient in the clonidine group and was higher in the control group O [three (15%) patients] than in the pregabalin group [one (5%) patient], with no significant statistical differences among the three groups.

No postoperative shivering was observed in any patient in group P or group C, whereas the incidence was 20% (four patients) in group O; this result was statistically significant.

Postoperative dizziness in group P was higher [six (30%) patients] compared with group O [two (10%) patients], and there was no dizziness observed in any patient in group C (0%). This result was statistically significant.

Postoperative mean VAS for static and dynamic pain assessment showed a statistically significant decrease in premedicated groups in comparison with the control group at 0, 0-4, and 4-8 time intervals. During the later hours of study (8-12 and 12-24 h), there was no statistically significant difference in the postoperative mean VAS among the studied groups. The highest VAS value in the time period defined was considered ([Figure 9] and [Figure 10]).
Figure 9: A comparison between studied groups as regards mean visual analogue scale for static pain.

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Figure 10: A comparison between studied groups as regards mean visual analogue scale (VAS) for dynamic pain.

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Postoperative ketorolac and pethidine consumptions during the first 24 h showed a statistically significant decrease in group P and group C than in group O. In addition, the time to first analgesic dose was significantly longer in group P and group C than in group O ([Figure 11]).
Figure 11: Mean time for analgesic requirement (TAR); ketorolac and pethidine consumptions.

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  Discussion Top


Pregabalin and clonidine have been found by various authors [2],[3],[6] to blunt the hemodynamic response for laryngoscopy and pneumoperitoneum when used as an oral premedication. Further, they decrease anesthetic and analgesic requirement during both intraoperative and postoperative periods [7] .

The present study evaluated the clinical efficacy of oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopy with monitoring of postoperative pain and analgesic requirement in patients undergoing laparoscopic cholecystectomy.

Elderly patients were excluded because they may take drugs such as antidepressants, hypnotics, and antihypertensives with increased sensitivity to anesthetic medications. Moreover, the safety and effectiveness of pregabalin in patients younger than 18 years have not been established [8] .

Pregabalin has been used in doses ranging from 50 mg 9 , 75 mg 10 , 100 mg 11 , 150 mg 3 , 300 mg [8],[12],[13] to 600 mg [14] . In the present study, pregabalin 300 mg was chosen fearing that smaller doses may not achieve a effective decrease in postoperative pain and analgesic consumption.

A dose-ranging study conducted on 108 patients undergoing elective surgery by Baidya et al. [15] found that, in the pregabalin 300 mg group, sedation scores were higher compared with the control group during the preinduction period and at 90 and 120 min postoperatively. Pregabalin exhibits a significant opioid-sparing effect in the first 24 h and a significant reduction in opioid-related adverse effects (vomiting).

The Ramsay Sedation Scale was higher without any sign of respiratory depression and without prolonged recovery times in the oral pregabalin group (group P) than in the oral clonidine group (group C). However, the difference between the two groups was statistically nonsignificant.

Gupta et al. [3] evaluated the clinical efficacy of oral premedication with pregabalin (150 mg) and clonidine (200 μg) and they used a 10 cm VAS for sedation (fully awake to extremely drowsy) and for anxiety scale (fully calm to worst possible anxiety). A clear increase in sedation (>6 cm) and a moderate decrease in anxiety (2.4-3.6 cm) were observed in both premedicated groups as compared with the control groups.  Preoperative anxiolysis and sedation were higher in oral the pregabalin group compared with the clonidine group. Moreover, there was no statistically significant difference among groups as regards recovery time. These results are in agreement with the current study despite the smaller dose of pregabalin (150 mg) used by Gupta et al. [3] Moreover, Baidya et al. [15] found that, in the pregabalin 300 mg group, sedation scores were higher compared with the control group during the preinduction period and at 90 and 120 min postoperatively.

Nasr and Abdellatif [16] compared the efficacy of melatonin and pregabalin on perioperative anxiety and postoperative pain in 40 patients undergoing laparoscopic gynecological surgeries. They found that the anxiety scores decreased significantly to greater than 50% after premedication in both groups compared with baseline values, with no statistically significant difference between the two groups. This may be attributed to a novel mechanism of action of pregabalin as it binds potently and selectively to the α2d subunit of 'hyperexcited' voltage-gated calcium channels, which changes their conformation, reducing calcium influx at nerve terminals. Pregabalin only modulates the release of excitatory neurotransmitters in 'hyperexcited' neurons, restoring them to normal physiological state. This newly defined mechanism of action is believed to confer on pregabalin its anxiolytic, analgesic, and anticonvulsant properties [17] .

On the other hand, clonidine works as an α2-adrenergic agonist, which has sedative and anxiolytic properties. The site of action of this group of drugs is probably on the pontine nucleus locus coeruleus, causing inhibition of the firing of locus coeruleus, which produces anxiety and hypertension [18] .

Neither pregabalin nor clonidine prolonged recovery times, although they are well known for their sedative properties. This may be explained by the concomitant intraoperative anesthetic-sparing effects [3] .

The present study showed that the preoperative administration of oral pregabalin 300 mg or oral clonidine 200 μg has significantly reduced the intraoperative heart rate, mean arterial blood pressure values during direct laryngoscopy, and endotracheal intubation. Even in the PACU, cardiovascular parameters remained at a lower level in the pregabalin group and the clonidine group without a significant difference between the two premedication drugs. When compared with the control group, it was found that premedication with clonidine or pregabalin blunts the stress response to surgical stimuli, and hence no hypertension or tachycardia was documented in premedicated groups.

The current study results are in agreement with the studies by Singh and Arora [2] , Montazeri et al. [19] , and Rastogi et al. [7] , who demonstrated that hemodynamic pressor response of airway instrumentation was attenuated by the use of premedication with oral pregabalin or clonidine. Greater hemodynamic stability was found with the use of clonidine, and this as well is in agreement with our work.

Several mechanisms may contribute to the attenuation of pressor response by pregabalin, which include the modulation of visceral pain and central sensitization [7] . Pregabalin inhibits membrane voltage-dependent Ca 2+ channels acting in a manner similar to calcium channel blockers in controlling the hemodynamic response [20] . Memis and colleagues reported that the inhibitions of Ca 2+ efflux from muscle cells with a consequent inhibition of smooth muscle relaxation might explain the effectiveness of gabapentinoids in the relaxation of laryngoscopy [20],[21] .

The hemodynamic stability in the oral clonidine group during the present study may be explained by several mechanisms, such as activation of central α2-adrenoceptors, which causes both a decrease in peripheral sympathetic tone and an increase in vagally induced reflex bradycardia. Moreover, stimulation of peripheral presynaptic α-adrenoceptors leads to a diminished release of norepinephrine from the nerve endings toward the vasculature and thereby reduces the peripheral sympathetic tone [19] .

The advantages of using pregabalin or clonidine premedication for attenuation of cardiovascular responses to the laryngoscopy are easy administration and availability with low price. Many drugs are used to attenuate the sympathetic response to laryngoscopy and intubation, such as remifentanil, which is expensive and has adverse effects such as bradycardia and hypotension that inhibits its use in hemodynamically compromised patients. Esmolol needs infusion pump for administration and it is not available always everywhere. Labetolol is an appropriate drug for this purpose but it is expensive and not available everywhere.

There were some intraoperative side effects recorded in the present study. The incidence of intraoperative bradycardia was (three patients) 15% in the clonidine group, and there was no bradycardia observed in any patient in group P or group O (0%). The results were statistically significant.

In the clonidine group, the incidence of intraoperative hypotension was higher (20%) compared with group P (10%), and there was no hypotension observed in any patient in group O (0%) and no significant statistical differences among groups. Our results for oral clonidine are in agreement with Singh and Arora [2] who reported that bradycardia and hypotension were found only in the clonidine group and was also statistically nonsignificant, and this may be due to its central effect on α2-receptor [22] .

Plasma levels of epinephrine and norepinephrine measured intraoperatively before induction and after intubation demonstrated significantly lower values in the pregabalin group and the clonidine group compared with the control group, without a significant difference between the two premedicated groups. This indicates a minor stress response in premedicated patients. As for clonidine, this may be attributed to its effect on α2-adrenergic receptors, which directly suppresses the impulses arising from the brain that otherwise would lead to increases in plasma epinephrine and norepinephrine concentration [23] .

On the other hand, regulation of neurotransmitter and hormone release by pregabalin is likely complex and might involve effects on the transmitter release machinery, in addition to altered Ca 2+ entry and/or altered excitability in neuronal circuits [24] .

The present study showed that the preoperative administration of oral pregabalin 300 mg or clonidine 200 μg significantly reduces the intraoperative fentanyl requirements and end-tidal isoflurane concentrations required to maintain an adequate depth of anesthesia. Importantly, we used an objective, qualitative measure of anesthetic state (BIS) to guide anesthetic requirements. This is in agreement with the work of Singh and Arora [2] , Gupta et al. [3] , Sung et al. [25] , and Morris et al. [26] .

The incidence of postoperative shivering was 20% (four patients) in group O, whereas in group P and group C no shivering was observed in any patient (0%). On comparing the three groups together, there was a statistically significant difference. This is in agreement with the findings of Gupta et al. [3] and Tripathi et al. [27] , who stated that clonidine could be used as an effective perioperative antishivering agent as it inhibits the cold thermoregulatory response due to an effect on central integration control and output from the thermoregulatory center [27] .

The present study showed a significant decrease in postoperative pain scores in most times of measurement in group P and group C if compared with group O. Moreover, there was a significantly lower ketorolac and pethidine consumption with an increase in mean time for analgesic requirement in the pregabalin and clonidine groups compared with the control group.

Pain after surgery is normally perceived as nociceptive pain. However, surgical trauma has been known to induce hyperalgesia, which can contribute to persistent postoperative pain after surgery. In contrast to traditional analgesics that are antinociceptive, gabapentinoids such as gabapentin and pregabalin reduce the hyperexcitability of dorsal horn neurons induced by tissue damage rather than reducing the afferent input from the site of tissue injury [28] . Gabapentinoids have been recommended for perioperative administration to improve acute pain after surgery by preventing the development of central sensitization [28],[29] .

Clonidine has antinociceptive actions at the spinal and supraspinal sites and synergistic analgesic effects with opioids [30] . A major advantage of clonidine over opioid analgesics is its lower potential for respiratory depression. The low cost and availability of clonidine is also a point in its favor [31] .

Our results for postoperative pain control with oral clonidine coincide with the results obtained by Singh and Arora [2] , Blaudszun et al. [22] , and Sung et al. [25] . Further, our results for oral pregabalin are in agreement with those of Eskandar and Ebeid [8] and Przesmycki et al. [32] .

This study confirms that oral premedication with pregabalin 300 mg or clonidine 200 μg produces sedation and hemodynamic stability during laparoscopic cholecystectomy and a decrease in postoperative pain and analgesic consumption.

Acknowledgements

The funding for this study is provided by Faculty of Medicine, Menoufia University.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11]
 
 
    Tables

  [Table 1]MenoufiaMedJ_2016_29_3_530_198695_t12.jpg, [Table 2]MenoufiaMedJ_2016_29_3_530_198695_t13.jpg



 

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