Pregabalin Reduce the Sevoflurane Requirement

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

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.

Study Overview

• Status: Completed
• Conditions: Elective Laparoscopic Cholecystectomy; Sevoflurane Anesthesia
• Intervention / Treatment: Drug: pregabalin; Drug: pregabalin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 31, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2012
• Last Update Submitted That Met QC Criteria: May 4, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: sevoflurane; pregabalin; Anesthesia; laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: R/49