Pregabalin Reduce the Sevoflurane Requirement

Study Overview
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Brief Summary
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Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.

Detailed Description
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laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.

Official Title
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Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.

Conditions
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Elective Laparoscopic Cholecystectomy, Sevoflurane Anesthesia

Intervention / Treatment
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* Drug: Placebo
* Drug: pregabalin
* Drug: pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists class I and II scheduled for elective laparoscopic cholecystectomy under sevoflurane anesthesia Exclusion Criteria: communication barriers cardiovascular diseases renal diseases hepatic diseases endocrinal diseases neuropsychiatric diseases prolonged P-R interval pregnancy nursing hypersensitivity treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregabalin 150 mg group<br>one capsule of pregabalin 150 mg and one placebo capsule | Drug: pregabalin<br>* one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery<br>|
| Active Comparator: pregabalin 300 mg group<br>two capsules of pregabalin 150 mg | Drug: pregabalin<br>* two capsules of pregabalin 150 mg 1 hr before surgery<br>|
| Placebo Comparator: placebo group<br>to receive two identical placebo capsules | Drug: Placebo<br>* to receive two identical placebo capsules 1 hr before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the end tidal sevoflurane concentrations | End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure. | intraoperative every 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic parameters | heart rate and mean arterial blood pressure were recorded before (baseline), 45 min after the administration of the study capsules; every 15 min after intubation until the skin closure and every 15 min for the first hour after extubation. | before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery | 
| intraoperative fentanyl supplementations | intraoperative fentanyl supplementations | intraoperative, an expected average of 2 hours | 
| quality of tracheal extubation | The quality of tracheal extubation was evaluated using a 5 - points rating scale: 1, no coughing or straining; 2, very smooth, minimal coughing; 3, moderate coughing; 4, marked coughing or straining; and 5, poor extubation, very uncomfortable | up to 24 after surgery | 
| postoperative cumulative morphine consumption | postoperative cumulative morphine consumption | up to 24 after surgery | 
| postoperative sedation and pain scores | Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep) | up to 24 after surgery | 
| postoperative nausea and vomiting | nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting) | up to 24 after surgery | 
| awareness and recall | The patients were asked about intraoperative awareness and recall on the second postoperative day by asking three simple questions using standard interview What was the last thing you remembered happening before you went to sleep? What is the first thing you remember happening on waking? Did you dream or have any other experiences whilst you were asleep? | intraoperative, an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, pregabalin, sevoflurane, laparoscopic cholecystectomy