| CTRI Number |
CTRI/2021/06/034217 [Registered on: 14/06/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of dexmedetomidine and magnesium sulphate in controlling the stress response of intubation in patients undergoing operation. |
|
Scientific Title of Study
|
A comparative study on dexmedetomidine and magnesium sulphate on the attenuation of the stress response of laryngoscopy and intubation in patients undergoing general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yangchen Bhutia |
| Designation |
Post graduate student |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical sciences.
Imphal West
MANIPUR
795004
India |
| Phone |
7908184386 |
| Fax |
|
| Email |
tansuflurries24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanasam Sarat Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences.
Imphal West
MANIPUR
795004
India |
| Phone |
7005683433 |
| Fax |
|
| Email |
dr_saratsanasam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanasam Sarat Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences.
Imphal West
MANIPUR
795004
India |
| Phone |
7005683433 |
| Fax |
|
| Email |
dr_saratsanasam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Lamphelpat, Imphal-795004, Manipur, India. |
|
|
Primary Sponsor
|
| Name |
Yangchen Bhutia |
| Address |
Post Graduate Trainee, Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal-795004, Manipur, India. |
| 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 |
| Yangchen Bhutia |
Regional Institute of Medical Sciences |
Department of Anaesthesiology,
Regional Institute of Medical Sciences.
Imphal West
MANIPUR |
7908184386
tansuflurries24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS, Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine intravenous |
Injection Dexmedetomidine 0.5ug/kg diluted to 10ml normal saline administered intravenously over 10 minutes before induction. |
| Comparator Agent |
Injection Magnesium sulphate intravenous |
Injection Magnesium sulphate 20mg/kg diluted to 10ml normal saline administered intravenously over 1 minute before induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
Patients with ASA physical grade I or II
Patients with age group 18 to 60 years undergoing elective surgery under general anesthesia
Patients willing to give written consent |
|
| ExclusionCriteria |
| Details |
Patients refusal
Anticipated difficult airway (mallampati score >III, thyromental distance <6.5cm)
Patients with diabetes and hypertension
Pregnant or breast feeding mother
Patients with respiratory, cardiac,neurological,renal or liver diseases
Patients with gastro-oesophageal reflux
Patients with known allergy to drugs used for induction of anaesthesia
Psychiatric patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of dexmedetomidine and magnesium sulphate on the attenuation of stress response of laryngoscopy and intubation in patients undergoing general anaesthesia. |
Baseline
Before intubation, just after intubation ,and also at 1,3,5,10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare between dexmedetomidine and magnesium sulphate, a better drug for controlling the stress response. |
Baseline
Before intubation, just after intubation, and also at 1,3,5,10 minutes after intubation |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2021 |
| 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="8"
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 study is a randomized, parallel group, placebo controlled double blinded trial to evaluate and compare the stress response attenuation between dexmedetomidine and magnesium sulphate in patients undergoing laryngoscopy and intubation. The study will be conducted in Department of Anaesthesiology, Regional institute of medical sciences, Imphal, Manipur, India. A total of 90 patients aged 18-60 years of either sex, ASA grade I and II will be randomly divided into three groups of 30 each and will be administered with the study drugs intravenously. Group D will receive Injection dexmedetomidine 0.5ug/kg diluted to 10ml normal saline, Group M will receive magnesium sulphate 20mg/kg diluted to 10ml normal saline and Group S will receive 10ml normal saline. Endotracheal intubation will be attempted and hemodynamic changes and adverse effects will be noted in each group, before, just after intubation and also at 1,3,5,10 minutes after intubation. |