Pregabalin Reduce the Sevoflurane Requirement

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Sevoflurane Anesthesia; Elective Laparoscopic Cholecystectomy

Treatments: Drug: pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01571804

R/49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

pregabalin 150 mg group

Active Comparator group

Description:

one capsule of pregabalin 150 mg and one placebo capsule

Treatment:

Drug: pregabalin

Drug: pregabalin

pregabalin 300 mg group

Active Comparator group

Description:

two capsules of pregabalin 150 mg

Treatment:

Drug: pregabalin

Drug: pregabalin

placebo group

Placebo Comparator group

Description:

to receive two identical placebo capsules

Treatment:

Drug: Placebo