CTRI/2023/12/060681尚未招募2/3 期
A Randomized controlled trial to compare the postoperative analgesia and haemodynamic response between Opioid Free Anaesthesia regimen(OFA) and standard opioid anaesthesia technique among patients undergoing laparoscopic non cardiac surgeries.
DrAshu Sara Mathai1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative haemodynamic stability (heart rate,blood pressure)
研究概览
简要总结
This study is Randomized controlled single centre trial to compare the intraoperative haemodynamic stability, Postoperative analgesia and post operative adverse effects in terms of nausea and vomiting, sedation, respiratory depression, pruritis, ileus, heamodynamic instability of an opioid free anaesthesia regimen versus standard opioid based anaesthesia regimen in patients undergoing non cardiac laparoscopic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of anaesthesiologist (ASA) classification I,II,III Patients undergoing elective, laparoscopic, non cardiac surgeries of less than 4 hours duration.
排除标准
- •Patients who refuse consent/lack the capacity to give consent Patient with known allergy to the study drugs used Patient with co-existing liver or renal disease Patients undergoing conversion to open surgical technique Patients with preoperative uncontrolled hypertension (Preoperative BP>190/110 mmhg) or hypotension (MAP<65 mmhg) Pregnancy Patients with Seizure disorder Patients with psychiatric illnesses or on antipsychotic medications Patients with Cardiac arrhythmias /AV block/ Bradycardia (<50/min).
结局指标
主要结局
Intraoperative haemodynamic stability (heart rate,blood pressure)
时间窗: Intraoperative haemodynamic stability (heart rate,blood pressure) | at 0,3,6,12,24 hours
post operative analgesia using Numerical Rating Score
时间窗: Intraoperative haemodynamic stability (heart rate,blood pressure) | at 0,3,6,12,24 hours
次要结局
- Ramsay sedation score(24hours)
- gastrointestinal recovery after surgery,haemodynamic instability,postoperative nausea and vomiting, respiratory depression,pruritus(24hours)
- quality of Recovery-15(24 hours)
研究者
研究点 (1)
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