Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Inhalational anaesthetic drug requirements
研究概览
简要总结
In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) may be effective in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60 years, schedule for elective abdominal hysterectomy surgery under general anesthesia.
详细描述
In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) would be effective in reducing intraoperative isoflurane requirement needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for elective abdominal hysterectomy surgery under general anaesthesia.
The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements) in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, aged 18-60 year scheduled for elective abdominal hysterectomy surgery under general anaesthesia.
- •American Society of Anaesthesiology (ASA) physical status I or II.
排除标准
- •American Society of Anaesthesiology (ASA) physical status ≥ III.
- •Allergy or hypersensitivity to pregabalin.
- •Patient on calcium channel blocker or anticonvulsant.
研究组 & 干预措施
pregabalin group
干预措施: Pregabalin (Drug)
placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Inhalational anaesthetic drug requirements
时间窗: an average of 3 hours after induction
Inhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.
次要结局
- pressor response attenuation(an average of 10 minutes after induction)
- First time for analgesics requirement(postoperative (maximum 6 hours after the end of operation))
研究者
Nesrine El-Refai
professor
Cairo University