| CTRI Number |
CTRI/2025/08/093678 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Nalbuphine on hemodynamics during laryngoscopy in general anaesthesia for ENT surgeries |
|
Scientific Title of Study
|
EVALUATE OF HAEMODYNAMIC RESPONSE OF INTRAVENOUS NALBUPHINE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION IN SURGERIES OF EAR NOSE THORAT (ENT) DONE UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruv Shah |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,2nd floor,Shalinitai Meghe Superspeciality Hospital,AVBRH Campus,Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9082498622 |
| Fax |
|
| Email |
dhruv191701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYASHREE SEN |
| Designation |
PROFESSOR |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
DEPARTMENT OF ANAESTHESIA, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION , SAWANGI (MEGHE), WARDHA, MAHARASHTRA
AVBRH
Wardha
MAHARASHTRA
442001
India |
| Phone |
9813061192 |
| Fax |
|
| Email |
jayashree_sen@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhruv Shah |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia,2nd floor,Shalinitai Meghe Superspeciality Hospital,AVBRH Campus,Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9082498622 |
| Fax |
|
| Email |
dhruv191701@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Wardha, Sawangi, Maharashtra 442004 |
| Type of Sponsor |
Private medical college |
|
|
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 Dhruv Shah |
Jawaharlal Nehru Medical College |
Department of Anaesthesia,2nd loor,Shalinitai Meghe Superspeciality Hospital,AVBRH campus
Wardha
MAHARASHTRA |
9082498622
dhruv191701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Datta Meghe Institute of Higher Education and 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 |
Nalbuphine |
Intravenous Nalbuphine 150 microgram per Kg will be given for reducing anxiety during induction of anaesthesia with orotracheal intubation. Assessment will be done in 1 hours. |
| Comparator Agent |
Normal saline |
Intravenous normal saline will be given for reducing anxiety during induction of anaesthesia with orotracheal intubation. Assessment will be done in one hour. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of elective ENT procedures under GA.
Patients weighing between 40 to 80kg.
Patients belonging to ASA grade I and II.
Patients with anticipated difficult airways according to LEMON criteria. |
|
| ExclusionCriteria |
| Details |
Patients with known drug allergy.
Patients of emergency surgeries.
Patients belonging to ASA grade III or higher.
Patients with uncontrolled systemic disease.
Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nalbuphine IV (150mcg/kg) injected before induction of elective surgeries in ENT to be done under general anaesthesia will effectively attenuate the hemodynamic stress response of orotracheal intubation |
T0-Baseline premedication vitals,T1-3 minutes after administration of Nalbuphine,T2-1 minute after induction and intubation,T3-3 minutes after intubatin,T4-5 minutes after intubation,T5-10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Endotracheal Laryngoscopy are crucial concerns in geeneral anaesthesia and can lead to life threatening changes.Intravenous Nalbuphine attenuates such hemodynamic changes.Study aims to assess the effectiveness of intravenous nalbuphine in reducing anxiety during intubation in ENT surgeries under general anaesthesia.One group will recieve nalbuphine intravenously and a control group wil recieve saline.Hemodynamic parameters will be measured at different times.The nalbuphine group is expected to have a significantly reduced magnitude of hemodunamic response as compared to the placebo group.Also,nalbuphine is expected to have a good safety profile with no significant adverse effects. |