Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- changes in the end tidal sevoflurane concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists class I and II
- •scheduled for elective laparoscopic cholecystectomy
- •under sevoflurane anesthesia
排除标准
- •communication barriers
- •cardiovascular diseases
- •renal diseases
- •hepatic diseases
- •endocrinal diseases
- •neuropsychiatric diseases
- •prolonged P-R interval
- •pregnancy
- •hypersensitivity
- •treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
研究组 & 干预措施
pregabalin 150 mg group
one capsule of pregabalin 150 mg and one placebo capsule
干预措施: pregabalin (Drug)
pregabalin 300 mg group
two capsules of pregabalin 150 mg
干预措施: pregabalin (Drug)
placebo group
to receive two identical placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
changes in the end tidal sevoflurane concentrations
时间窗: intraoperative every 15 min
End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.
次要结局
- hemodynamic parameters(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, an expected average of 2 hours)
- quality of tracheal extubation(up to 24 after surgery)
- postoperative cumulative morphine consumption(up to 24 after surgery)
- postoperative sedation and pain scores(up to 24 after surgery)
- postoperative nausea and vomiting(up to 24 after surgery)
- awareness and recall(intraoperative, an expected average of 2 hours)
研究者
Mohamed R El Tahan
Principal Investigator
Mansoura University