Comparison of surgical pleth index guided analgesia with conventional analgesia technique for total intraoperative fentanyl consumption in patients undergoing modified radical mastectomy under general anaesthesia
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total intraoperative fentanyl consumption in microgram will be measured in surgical pleth index guided analgesia technique and conventional analgesia technique
研究概览
简要总结
This prospective randomised parallel group interventional trial will include female patients aged 18-65 years
Two groups will be formed
Group 1 SPI Guided-fentanyl 0.5 microgram/kg admistered whenever SPI greater than 50
Group 2 Conventional- Fentanyl 0.5 micrograms/kg given hourly after induction and additionally if HR or SBP rise greater than 20 percent from baseline
All patients will undergo standardised anaesthesia induction with midazolam fentanyl propofol and vecuronium and maintenance with sevoflurane titrated to maintain entropy between 40-60
The primary outcome will be total intraoperative fentanyl consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA physical status 1 or 2 BMI between 18.5 and 30 kg/m2.
排除标准
- •Allergy or hypersensitivity to fentanyl or study drugs Chronic opioid use or analgesic dependence Cardiovascular instability Autonomic dysfunction or peripheral vascular disease Severe hepatic or renal impairment Pregnant or lactating women.
结局指标
主要结局
Total intraoperative fentanyl consumption in microgram will be measured in surgical pleth index guided analgesia technique and conventional analgesia technique
时间窗: Baseline HR and SBP will be noted then intraoperative HR,SBP and fentanyl total doses will be noted
次要结局
- 1.Postoperative pain score in the form of numerical rating score(NRS) in recovery(2.Incidence of post operative nausea vomiting in recovery)
研究者
Riya Choudhary
ABVIMS and Dr. RML Hospital