| CTRI Number |
CTRI/2024/05/067274 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative study of two drugs |
|
Scientific Title of Study
|
Comparison Of Intravenous Infusion of Dexmedetomidine Versus Labetalol for Attenuation of Hemodynamic Stress Response During Laryngoscopy and Intubation
|
| 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 Ambati Mounika |
| Designation |
Postgraduate |
| Affiliation |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
| Address |
Dr Pinnamaneni Siddhartha Institute Of
Medical Sciences and Research Foundation
Department of Anesthesia and Critical care
Chinna avutapalli
Gannavaram Mandal
Krishna District
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
8500945891 |
| Fax |
|
| Email |
ambatimounika00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Sankar Rao |
| Designation |
Associate Professor |
| Affiliation |
Dr Pinnamaneni Siddhartha Institute of Medical sciences and Research Foundation |
| Address |
Dr Pinnamaneni Siddhartha Institute of Medical sciences and Research Foundation
Department of Anesthesia and Critical care
Chinna Avutapalli
Gannavaram Mandal
Krishna District
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7702028888 |
| Fax |
|
| Email |
drshankar1811974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Sankar Rao |
| Designation |
Associate Professor |
| Affiliation |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research foundation |
| Address |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research foundation
Department of Anesthesia and Critical care
Chinna Avutapalli
Gannavaram Mandal
Krishna District
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7702028888 |
| Fax |
|
| Email |
drshankar1811974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation
Chinna Avutapalli
Gannavaram Mandal
Krishna District
521286
INDIA
|
|
|
Primary Sponsor
|
| Name |
Dr Ambati Mounika |
| Address |
Dr Pinnamaneni Siddhartha Institute Of
Medical Sciences and Research Foundation
Department of Anesthesia and Critical care
Chinna avutapalli
Gannavaram Mandal
Krishna District
521286 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ambati Mounika |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research foundation |
Department of Anesthesia and Critical care
Chinna Avutapalli
Gannavaram Mandal
Krishna District
521286
Krishna
ANDHRA PRADESH |
08500945891
ambatimounika00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Pinnamaneni Siddhartha Institute of Medical sciences and Research foundation |
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 |
LABETOLOL |
Labetalol 0.25mg/kg in 10ml normal saline iv over 10min 5min before induction of anesthesia |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 1 µg/kg in 10ml normal saline iv over 10 min 5min before induction of anesthesia
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of ASA grade 1 and 2 who are undergoing
elective surgery under general anesthesia
2 Patients who consent to participate in the study
3 Patients having informant available
|
|
| ExclusionCriteria |
| Details |
1 Difficult airway
2 Hypertension
3 Diabetes mellitus
4 ischemic heart disease
5 renal diseases
6 Cerebrovascular Disease
• Patients on beta blockers
alpha blockers
• Bronchial asthma
• Allergy to study drug
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmeditomidine 1µ/Kg given slowly over 10 minutes intravenously 5 minutes prior to induction, attenuates the cardiovascular responses to laryngoscopy and intubation in a better manner than Labetalol 0.25mg/Kg. |
post intubation vitals are measured every 3minutes for first 15minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect of Dexmedetomidine in attenuating the hemodynamic stress response during Laryngoscopy and intubation
2)To observe the effect of labetalol in attenuating hemodynamic stress response during Laryngoscopy and Intubation
3)To compare between Dexmedetomidine and Labetalol in the specified dosage.
|
post intubation vitals are measured every 3minutes for first 15minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
31/05/2024 |
| 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 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
|
Tachycardia hypertension and dysrhythmias all occur during Laryngoscopy and intubations. The consequent rise in rate or pressure may result in myocardial oxygen demand which exceeds the oxygen supply resulting in myocardial ischemia. This response is sympathetically mediated and can be attenuated by various drugs that block sympathetic activity and other drugs like calcium channel blocking drugs Lignocaine and magnesium sulphate.
This study aims at comparing efficacy of dexmedetomidine versus Labetalol in attenuating hemodynamic stress response during laryngoscopy and intubation. |