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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bhaktivedanta Hospital and Research Institute
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- 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."
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All ASA-I and ASA-II, female patients getting operated for laparoscopic hysterectomy and consenting to be part of study will be included.
Exclusion Criteria
- •Grade ASA III and above patients
- •Patients not giving consent
- •Patients undergoing laparoscopic hysterectomy as a part of cytoreduction will be excluded from study.
Outcomes
Primary Outcomes
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."
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Dr Shilpa Tiwaskar
Bhaktivedanta Hospital and Research Institute