Pregabalin Reduce the Sevoflurane Requirement

Phase 2

Completed

• Conditions: Elective Laparoscopic Cholecystectomy; Sevoflurane Anesthesia
• Interventions: Drug: Placebo; Drug: pregabalin

• Registration Number: NCT01571804
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Study First Submitted: 2012-03-31
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	to receive two identical placebo capsules
pregabalin 150 mg group	pregabalin	one capsule of pregabalin 150 mg and one placebo capsule
pregabalin 300 mg group	pregabalin	two capsules of pregabalin 150 mg

Primary Outcome Measures

Name	Time	Method
changes in the end tidal sevoflurane concentrations	intraoperative every 15 min	End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.

Secondary Outcome Measures

Name	Time	Method
hemodynamic parameters	before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery	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.
intraoperative fentanyl supplementations	intraoperative, an expected average of 2 hours	intraoperative fentanyl supplementations
quality of tracheal extubation	up to 24 after surgery	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
postoperative cumulative morphine consumption	up to 24 after surgery	postoperative cumulative morphine consumption
postoperative sedation and pain scores	up to 24 after surgery	Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep)
postoperative nausea and vomiting	up to 24 after surgery	nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)
awareness and recall	intraoperative, an expected average of 2 hours	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?"

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, DK, Egypt