A single- centre, prospective, observational, two arm study to compare effects of intravenous fentanyl with intravenous nalbuphine for laparoscopic hysterectomy in terms of intraoperative hemodynamics, postoperative analgesia and postoperative side-effects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To compare intraoperative hemodynamics, postoperative analgesia, and postoperative side effects (postoperative nausea and vomiting and respiratory distress) between patients receiving intravenous fentanyl and intravenous nalbuphine during laparoscopic hysterectomy."
研究概览
简要总结
This is a single-centre, prospective, observational, two-arm, open-label study comparing intravenous fentanyl and intravenous nalbuphine in patients undergoing elective laparoscopic hysterectomy under general anaesthesia. A total of 62 ASA I–II female patients will be enrolled and allocated to receive either fentanyl or nalbuphine prior to induction. The study will evaluate intraoperative hemodynamic stability, postoperative analgesic efficacy, and the incidence of postoperative side effects, specifically nausea, vomiting, and respiratory distress. The findings aim to determine whether nalbuphine provides a safer and more effective alternative to fentanyl for perioperative analgesia in laparoscopic hysterectomy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •All ASA-I and ASA-II, female patients getting operated for laparoscopic hysterectomy and consenting to be part of study will be included.
排除标准
- •Grade ASA III and above patients
- •Patients not giving consent
- •Patients undergoing laparoscopic hysterectomy as a part of cytoreduction will be excluded from study.
结局指标
主要结局
To compare intraoperative hemodynamics, postoperative analgesia, and postoperative side effects (postoperative nausea and vomiting and respiratory distress) between patients receiving intravenous fentanyl and intravenous nalbuphine during laparoscopic hysterectomy."
时间窗: Intraoperative hemodynamics, postoperative analgesia, and postoperative 15 minutes, 30 minutes, 45 minutes, 01 hour, 01 hour 15 minutes, 1 hour 30 minutes, 1 hour 45 minutes and 02 hours and 30 minutes post-oprative. side effects post-oprative nausea vomiting for 30 minutes, 1 hour, 2 hours and 03 hours.
次要结局
- 1. Comparison between Intra-operative Dose Requirement of Inj.Fentanyl and Inj.Nalbuphine to maintain stable Hemodynamics.(2. Comparison between patients on Inj.Fentanyl and Inj.Nalbuphine for Post-operative Rescue Analgesia Required.)
研究者
Dr Shilpa Tiwaskar
Bhaktivedanta Hospital and Research Institute