| CTRI Number |
CTRI/2023/01/049139 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine, esmolol and combination of both drugs to decrease stress response to intubation. |
|
Scientific Title of Study
|
Comparison of effect of intravenous Dexmedetomidine, Esmolol and combination of Esmolol and Dexmedetomidine for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shireen Singh |
| Designation |
Resident Doctor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL, NEW DELHI |
| Address |
ABVIMS AND DR RML HOSPITAL, Dept of Anaesthesiology, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7508472499 |
| Fax |
|
| Email |
shireen96.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalita Chaudhary |
| Designation |
Director Professor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
ABVIMS AND DR RML HOSPITAL, Dept of Anaesthesiology, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9968299710 |
| Fax |
|
| Email |
lalitachaudhary055@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shireen Singh |
| Designation |
Resident Doctor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
ABVIMS AND DR RML HOSPITAL, Dept of Anaesthesiology, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7508472499 |
| Fax |
|
| Email |
shireen96.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, ABVIMS and DR, RML HOSPITAL, New Delhi, 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS AND DR RML HOSPITAL |
| Address |
ABVIMS AND DR RML HOSPITAL, NEW DELHI, 110001 |
| 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 Shireen Singh |
ABVIMS and DR RML HOSPITAL |
Department of Anaesthesiology ABVIMS and DR RML HOSPITAL, NEW DELHI, 110001
New Delhi
DELHI |
7508472499
shireen96.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation |
Comparison of intravenous Dexmedetomidine(1mcg/kg),intravenous Esmolol (1mg/kg) and combination of intravenous Esmolol(0.5mg/kg) and Dexmedetomidine(0.5mcg/kg) for attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation |
| Comparator Agent |
Combination of intravenous Esmolol and Dexmedetomidine |
Dose of Esmolol : 0.5 mg/kg
Dose of Dexmedetomidine : 0.5 mcg/kg
Route of administration : Intravenous infusion
Duration of administration : 10 minutes |
| Comparator Agent |
Intravenous Dexmedetomidine |
Dose of Dexmedetomidine : 1mcg/kg
Route of administration : Intravenous infusion
Duration of infusion : 10 minutes |
| Comparator Agent |
Intravenous Esmolol |
Dose of Esmolol : 1 mg/kg
Route of administration : Intravenous bolus
Duration of administration : 30 sec |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anaesthesiologists(ASA) Physical status I and II Patients
2. Either sex
3. Age: 20 to 50 years
4. Elective surgical procedures |
|
| ExclusionCriteria |
| Details |
1. Known sensitivity to any study drug
2. Pregnant females
3. Patient with chronic hypertension and diabetes mellitus
4. Patient with history of cardiac or respiratory disease
5. Patient with anticipated difficult airway
6. Patient with impaired kidney or liver function
7. Patient on Beta blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response to Laryngoscopy and Endotracheal Intubation(HR,SBP,DBP,MAP) |
Baseline(at arrival in OT)
1 minute after Laryngoscopy and Endotracheal Intubation
3 minutes after Laryngoscopy and Endotracheal Intubation
5 minutes after Laryngoscopy and Endotracheal Intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biochemical markers of stress response(Serum cortisol and Blood glucose levels) |
Baseline(at arrival in OT)
5 minutes after Laryngoscopy and Endotracheal Intubation |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
20/02/2023 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients posted for elective surgeries under general anaesthesia will be assessed according to eligibility criteria. A total of 63 (21 in each group) patients will be selected. The procedure will be explained to the patients and informed, written consent will be obtained in a language that is understood by the patient. All standard monitors will be attached and baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be recorded. Intravenous access will be established and a venous sample for baseline serum cortisol and blood sugar levels will be taken. According to randomization into 3 groups, patients will be administered intravenous Dexmedetomidine (1 mcg/kg) in group 1, Esmolol (1 mg/ kg) in group 2 and combination of Esmolol (0.5 mg/kg) and Dexmedetomidine (0.5 mcg/kg) in group 3. Induction will be done followed by Laryngoscopy and Endotracheal Intubation. Hemodynamic monitoring will be done at 1, 3 and 5 minutes post-intubation and blood sampling for biochemical markers will be done at 5 minutes post-intubation. Statistical methods will be used to analyse collected data. |