| CTRI Number |
CTRI/2023/10/058666 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| 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
|
Use of low dose of Dexmedetomidine in Neurosurgical Patients for better outcomes |
|
Scientific Title of Study
|
A Comparative Analysis Of The Effects Of Two Different Infusion Doses Of Dexmedetomidine On Hemodynamic Response To Extubation And The Quality OF Extubation In The Neurosurgical Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MD Tausif Alam |
| Designation |
Junior Resident |
| Affiliation |
Rajendra institute of medical sciences, Ranchi , Jharkhand |
| Address |
2nd floor, old building, Department of Anaesthesiology, Rajendra institute of medical sciences , Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
7903816386 |
| Fax |
|
| Email |
tsf14318@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh kumar |
| Designation |
Associate Professor |
| Affiliation |
Rajendra institute of medical sciences, Ranchi , Jharkhand |
| Address |
2nd floor, old building, Department Of Anaesthesiology Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8709135297 |
| Fax |
|
| Email |
drkmukesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwanath Kumar |
| Designation |
Associate Professor |
| Affiliation |
RIMS Ranchi |
| Address |
Department Of Anaesthesia RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
8439512490 |
| Fax |
|
| Email |
drvishwanathkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences, P.O/P/S; Bariatu, Ranchi, zip; 834009, Jharkhand |
|
|
Primary Sponsor
|
| Name |
Rajendra institute of medical sciences |
| Address |
Rajendra institute of medical sciences,Ranchi, zip; 834009, Jharkhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Md Tausif alam |
Rajendra institute of medical sciences (RIMS) Ranchi Jharkhand |
Neurosurgical OT Rajendra institute of medical sciences,Ranchi , Jharkhand
Ranchi
JHARKHAND |
7903816386
tsf14318@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical committee, Rajenra Institute of medical sciences,Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (3) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine 0.4mcg/kg/hr ,
Dexmedetomidine 0.6mcg/kg/hr and
Placebo (Normal saline) 20ml |
20ml of Drug Solution in infused with the infusion pump at the rate of 60ml/hr just before the skin closure of Neurosurgical patient. Effects monitored for 20minutes |
| Intervention |
Dexmedetomidine 0.4mcg/kg/hr and Dexmedetomidine 0.6mcg/kg/hr |
20ml of Drug Solution in infused with the infusion pump at the rate of 60ml/hr just before the skin closure of Neurosurgical patient. Effects monitored for 20 minutes. To decrease the Stress response of extubations
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient giving informed and written consent
2.ASA physical class 1 and 2
3.Patient of supratentorial space occupying lesion
4.Glasgow coma scale 15/15 |
|
| ExclusionCriteria |
| Details |
1.Patient refusal, not giving consent for study.
2.Pregnant and lactating women.
3.Patients undergoing elective surgical procedures in prone position including surgery of spine.
4.Patient having known case of allergy to dexmedetomidine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the hemodynamic changes during tracheal extubation following two infusion doses of dexmedetomidine.
To observe the airway response during tracheal extubation |
30 minutes after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to emergence & time to tracheal extubation.
2.Early post operative complications such as coughing, laryngospasm,
bronchospasm.
3.Adverse effects of the drug if any, such as delayed arousal, bradycardia & hypotension. |
1 hour after tracheal extubation |
|
|
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)
|
21/10/2023 |
| 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="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
|
It is a triple blind RCT, of 3 groups with 30 participants in each group, it is a comparative analysis of the effects of two different infusion doses of dexmedetomidine on hemodynamic response to extubation and the quality of extubation in the neurosurgical patients. D1 group will receive drug at a dose 0.4mcg/kg/hr and D2 will receive drug at a dose rate of 0.6mcg/kg/hr and the group C. Will be the control group will receive Normal saline. 20ml of the solution will be started at the end of surgery for about 20min and the vitals and the quality of extubtion are recorded. |