Clinical trial NCT01571804: Pregabalin Reduce the Sevoflurane Requirement
Official title: Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Elective Laparoscopic Cholecystectomy
Sevoflurane Anesthesia
Keywords: Anesthesia
pregabalin
sevoflurane
laparoscopic cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 42
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in the end tidal sevoflurane concentrations
timeFrame: intraoperative every 15 min
Secondary outcomes:
measure: hemodynamic parameters
timeFrame: before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery
measure: intraoperative fentanyl supplementations
timeFrame: intraoperative, an expected average of 2 hours
measure: quality of tracheal extubation
timeFrame: up to 24 after surgery
measure: postoperative cumulative morphine consumption
timeFrame: up to 24 after surgery
measure: postoperative sedation and pain scores
timeFrame: up to 24 after surgery
measure: postoperative nausea and vomiting
timeFrame: up to 24 after surgery
measure: awareness and recall
timeFrame: intraoperative, an expected average of 2 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: DK
Study officials:
References: