| CTRI Number |
CTRI/2025/11/097025 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Glucagon drug during fast intubation technique in elderly patient on blood pressure reducing drug. |
|
Scientific Title of Study
|
Role of Glucagon during rapid sequence intubation (RSI) in elderly patients on beta blocker: A randomised controlled trial |
| 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 RAVI ANAND |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7739290418 |
| Fax |
|
| Email |
drravianand75@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAVI ANAND |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7739290418 |
| Fax |
|
| Email |
drravianand75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAVI ANAND |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma and Emergency Medicine, AIIMS Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7739290418 |
| Fax |
|
| Email |
drravianand75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani in the Department of Trauma and Emergency Medicine including common ICU and Trauma ICU |
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
Saguna, Kalyani Dist Nadia West Bengal, India, PIN 741245 |
| Type of Sponsor |
Government 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 RAVI ANAND |
Trauma ICU and Common ICU under Department of Trauma and Emergency Medicine at AIIMS Kalyani |
Department of Trauma and Emergency Medicine, AIIMS Kalyani
Saguna, Kalyani, West Bengal 741245
Nadia
WEST BENGAL |
07739290418
drravianand75@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of AIIMS Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rapid sequence intubation
|
RSI in an elderly patient on a beta blocker with Glucagon
Duration of intervention 30 second to 1 minute |
| Comparator Agent |
Rapid sequence intubation |
RSI without Glucagon
Duration 30 second to 1 minute
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patient on chronic beta blocker |
|
| ExclusionCriteria |
| Details |
Known renal dysfunction or visible jaundice
Patients already on vasopressors or inotropes at the time of evaluation
Cardiac arrest prior to or during intubation
Destitutes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of peri-intubation hypotension, defined as MAP more than 65 mmHg or a decrease less than 20% from baseline within 10 minutes of RSI. |
1. Incidence of peri-intubation hypotension, defined as MAP more than 65 mmHg or a decrease less than 20% from baseline within 10 minutes of RSI. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of bradycardia HR less than 50 bpm
Requirement of rescue vasopressors or atropine
First-pass intubation success rate
Occurrence of arrhythmias
Adverse effects attributable to glucagon
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drravianand75@yahoo.com].
- For how long will this data be available start date provided 15-01-2026 and end date provided 15-09-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
6 monRapid Sequence Intubation (RSI) is a critical intervention in emergency and critical care settings. However, elderly patients on chronic beta-blocker therapy duration more than ths are particularly vulnerable to peri-intubation hemodynamic instability, including significant hypotension and bradycardia. This is due to age-related physiological changes and the pharmacodynamic effects of beta-blockers, which blunt the body’s compensatory cardiovascular responses during stress. Current strategies, such as careful selection of induction agents like ketamine or etomidate, provide partial protection but may not fully address the underlying risks in beta-blocked patients. Glucagon, known for its role in managing beta-blocker overdose, offers a unique mechanism to stimulate cardiac activity by increasing intracellular cyclic AMP through non-beta-adrenergic pathways. Its ability to bypass blocked beta-receptors suggests it may be a valuable prophylactic agent in preventing hemodynamic compromise during RSI in this high-risk population. Despite theoretical support and limited case-based evidence, robust clinical data from randomised controlled trials are lacking. Therefore, there is a pressing need to systematically evaluate the role of glucagon in this setting. Objectives
Primary objective:
To determine whether pre-treatment with intravenous glucagon reduces the incidence of peri-intubation hypotension in elderly patients on chronic beta-blocker therapy undergoing RSI. Secondary objectives:
Assessing the incidence of bradycardia, need for rescue vasopressors or atropine, first-pass intubation success rates, occurrence of arrhythmias, and any adverse effects of glucagon. |