Pregabalin Reduce the Sevoflurane Requirement

Elective Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571804
• Other study ID #: R/49
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2012
• Last updated: May 4, 2012
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Laparoscopic Cholecystectomy
• Sevoflurane Anesthesia

Intervention

Drug:
• Placebo
to receive two identical placebo capsules 1 hr before surgery
• pregabalin
one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
• pregabalin
two capsules of pregabalin 150 mg 1 hr before surgery

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	intraoperative fentanyl supplementations	intraoperative fentanyl supplementations	intraoperative, an expected average of 2 hours	No
Secondary	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	No
Secondary	postoperative cumulative morphine consumption	postoperative cumulative morphine consumption	up to 24 after surgery	No
Secondary	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	No
Secondary	postoperative nausea and vomiting	nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)	up to 24 after surgery	Yes
Secondary	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	Yes