| CTRI Number |
CTRI/2025/03/083669 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Of Dexmedetomidine And Labetalol For Attenuation of Haemodynamic Stress Response to Laryngoscopy and Intubation |
|
Scientific Title of Study
|
A Comparative Study Of Dexmedetomidine And Labetalol For Attenuation of Haemodynamic Stress Response to Laryngoscopy and Intubation: A Randomized Clinical 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 |
Pranesh Gurung |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute Of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology
Regional Institute Of Medical Sciences Imphal
Imphal West
MANIPUR
795004
Imphal West
MANIPUR
795004
India |
| Phone |
8348580211 |
| Fax |
|
| Email |
Pranesh.grng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute Of Medical Sciences Imphal |
| Address |
Department of Anaesthesiology
Regional Institute Of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
8787458045 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Anita Devi |
| Designation |
Professor |
| Affiliation |
Regional Institute Of Medical Sciences Imphal |
| Address |
Department of Anaesthesiology
Regional Institute Of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
8787458045 |
| Fax |
|
| Email |
dranitadevin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology
Regional Institute Of Medical Sciences
Imphal West
Manipur
India
PIN-795004 |
|
|
Primary Sponsor
|
| Name |
Pranesh Gurung |
| Address |
Department Of Anaesthesiology
Regional Institute Of Medical Sciences
Imphal
Manipur |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
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 Pranesh Gurung |
Regional Institute Of Medical Sciences |
Operation Theatre complex.
Department of Anaesthesiology
Regional Institute Of Medical Sciences
Imphal
Imphal West
MANIPUR |
8348580211
pranesh.grng@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
Inj Dexmedetomidine 1mcg/kg |
Study participants will receive inj Dexmedetomidine 1mcg/kg in 10ml normal saline i.v over 10 mins, 5 minutes before induction of anaesthesia. |
| Comparator Agent |
Inj labetalol 0.5mg/kg |
Study participants will receive Inj Labetalol 0.5mg/kg in 10 ml normal saline i.v over 10 mins before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex
Patient with ASA physical grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Difficult airway
Uncontrolled Hypertension
Uncontrolled Diabetes Mellitus
Ischemic heart disease
Severe Renal disease
Cerebrovascular disease
Patient on beta blockers, alpha blockers
Bronchial Asthma
Allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes ( hypertension, tachycardia, hypotension, bradycardia) during laryngoscopy and intubation. |
Haemodynamic changes ( hypertension, tachycardia, hypotension, bradycardia) before starting infusion, 1 min after infusion, 1 min after induction, 1, 3 5, 15, 30 mins after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes ( hypotension, bradycardia) during laryngoscopy and intubation. |
Haemodynamic changes ( hypotension, bradycardia) before starting infusion, 1 min after infusion, 1 min after induction, 1, 3 5, 15, 30 mins after intubation. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/04/2025 |
| 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="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 - 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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [Pranesh.grng@gmail.com].
- For how long will this data be available start date provided 06-02-2025 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Laryngoscopy during endotracheal intubation produce mechanical and chemical stimulus that increase somatovisecral reflex caused by stimulation of epipharynxand laryngopharynx producing tachycardia and hypertension which may produce deleterious effects on comorbid patients. Hence, it is important to find ways to attenuate those responses during laryngoscopy and intubation.
A comparative randomized clinical trial will be carried out to evaluate the efficacy of dexmedetomidine and labetalol in attenuating hemodynamic responses during laryngoscopy and intubation. This study will involve 102 American Society of Anaesthesiologist grade I and II patients aged 18to 60, of both sexes undergoing elective surgeries under general anaesthesia.
Patients will be randomly assigned to receive either dexmedetomidine (Group A) 1 mcg/kg in 10ml normal saline (n=51) or labetalol (Group B) 0.5 mg/kg in 10ml normal saline(n=51) intravenously 5 minutes before induction of anaesthesia. Haemodynamic parameters will be monitored 1 min after infusion of study drug followed by 1 min after induction and 1, 3, 5, 10 and 15 minutes after intubation.
The findings and observations made during the study will be tabulated, graphically represented.The inference drawn from this comparative study will provide insights into the effectiveness of dexmedetomidine compared to labetalol in attenuating haemodynamic responses during laryngoscopy and intubation. |