| CTRI Number |
CTRI/2021/07/034519 [Registered on: 01/07/2021] Trial Registered Prospectively |
| Last Modified On: |
01/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Dexmedetomidine and Lignocaine in attenuating haemodynamic response to laryngoscopy and endotracheal intubation |
|
Scientific Title of Study
|
Attenuation of Haemodynamic response to Laryngoscopy and Endotracheal intubation with intravenous Dexmedetomidine and intravenous Lignocaine : A Comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruth Lalnuntawmpuii |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal West, Manipur, 795004
NIL
Imphal West
MANIPUR
795004
India |
| Phone |
9615489966 |
| Fax |
|
| Email |
ruthralte21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Longjam Eshori |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur
NIL
Imphal West
MANIPUR
795004
India |
| Phone |
9436036407 |
| Fax |
|
| Email |
drlongjam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Longjam Eshori |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur
NIL
Imphal West
MANIPUR
795004
India |
| Phone |
9436036407 |
| Fax |
|
| Email |
drlongjam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal, Manipur, 795004 |
|
|
Primary Sponsor
|
| Name |
Ruth Lalnuntawmpuii |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur, 795004 |
| 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 |
| Ruth Lalnuntawmpuii |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal |
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur, 795004
Imphal West
MANIPUR |
9615489966
ruthralte21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine |
0.75 mcg/kg of Dexmedetomidine IV given 5 minutes prior to induction with 2mg/kg Propofol |
| Comparator Agent |
Intravenous Lignocaine |
1.5mg/kg of Lignocaine IV given 5 minutes prior to induction with 2mg/kg Propofol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II and patients posted for elective surgery who has given consent |
|
| ExclusionCriteria |
| Details |
1. ASA grade III and IV
2. Uncontrolled hypertension, diabetes, cardiac, renal, hepatic, cerebral and peripheral vascular diseases
3. Bradycardia
4. Morbid obesity
5. History of allergy to study drugs
6. Patients in whom intubation attempts lasted longer than 15 seconds
7. Patients with anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic response to laryngoscopy and endotracheal intubation |
Haemodynamic response to laryngoscopy and endotracheal intubation duting intubation, 1 minute, 2 minutes, 3 minutes and 5 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
02/07/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study to compare the efficacy of 0.75mcg/kg of IV Dexmedetomidine and 1.5mg/kg of IV Lignocaine, in attenuating haemodynamic response to laryngoscopy and endotracheal intubation, which will be conducted in the department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, in 64 patients, aged 18-60 years, with ASA grade I and II. The study drug will be given 5 minutes prior to induction with 2mg/kg IV Propofol. The haemodynamic parameters will be recorded till 5 minutes post intubation and will be analysed. |