| CTRI Number |
CTRI/2025/08/093693 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta SwamiMarg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta SwamiMarg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta SwamiMarg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, SrishtiComplex, Mira Road East, Thane, Maharashtra, India 401107. |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East,Thane, Maharashtra, India 401107. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poornima Raut |
Bhaktivedanta Hospital and Research Institute |
OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex,Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA |
9833525816
poornimaraut08@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All ASA-I and ASA-II, female patients getting operated for laparoscopic hysterectomy and consenting to be part of study will be included. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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." |
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 Outcome
|
| Outcome |
TimePoints |
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.
|
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. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |