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A study in adult women undergoing laparoscopic hysterectomy to compare the effects of intravenous fentanyl and intravenous nalbuphine on blood pressure, pain relief, and side effects during and after surgery.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093693
Enrollment
62
Registered
2025-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Grade ASA III and above patients 2. Patients not giving consent 3. Patients undergoing laparoscopic hysterectomy as a part of cytoreduction will be excluded from study.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
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. Timepoint: 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.—

Countries

India

Contacts

Public ContactDr Shilpa Tiwaskar

Bhaktivedanta Hospital and Research Institute

drtiwaskar@gmail.com9820067137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026