Opioid-Free versus Opioid-Based Anaesthesia for Elective Laparoscopic Surgery - A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery.
研究概览
简要总结
The Study is to Compare theEfficacy of Opioid-Free and Opioid-Based Anaesthesia in terms ofIntraoperative Hemodynamic Stability and Post operative Analgesia in patientsundergoing Elective Laparoscopic Surgery under General Anaesthesia.
Thehypothesis in this study is an opioid-free anaesthetic regimenconsisting of both dexmedetomidine and ketamine infusions, along with intravenous(IV) paracetamol, and magnesium as a co-analgesic, is an effectivealternative anaesthetic technique, compared to the opioid-based anaesthetic regimenregarding intraoperative hemodynamic stability, postoperative pain intensity,and the incidence of side effects in the early post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI: 18.5 – 24.9 ASA (American Society of Anaesthesiologists) physical status of I and II.
排除标准
- •Pregnant and Lactating Women ASA physical status of III and IV Significant pain related neurological conditions Patients currently taking opioid Patients with allergies to study medication Patient Refusal H/O Drug Abuse, Psychiatric disease.
结局指标
主要结局
Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery.
时间窗: It will be monitored at baseline, before induction, post induction 3min, before intubation, post intubation 1 min, beginning of surgery, bef | ore abdominal insufflation, post abdominal insufflation 3min, 15 min,30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min & 150 min from induction , post deflation 3min, before extubation, after extubation 1min.
次要结局
- To compare the use of Postoperative Rescue Analgesia & the use of rescue for Postoperative Nausea & Vomiting.(Postoperative pain will be assessed by visual analog scale score at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours.)