| CTRI Number |
CTRI/2024/06/069049 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to find out the effect of the drug -dexmedetomidine as a premedication for induction of general anaesthesia with propofol. |
|
Scientific Title of Study
|
A study on the effect of Dexmeditomidine on the volume and dose of Propofol required to achieve loss of consciousness using Propofol based Marsh model of target controlled infusion. |
| 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 Neeraja K R |
| Designation |
Junior resident,Dept of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,Uttar pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9048995518 |
| Fax |
|
| Email |
kr.neeraja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Obaid Ahmad Siddiqui |
| Designation |
Associate professor,Dept of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,Uttar pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraja K R |
| Designation |
Junior resident,Dept of Anaesthesia |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,Uttar pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9048995518 |
| Fax |
|
| Email |
kr.neeraja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Jawaharlal Nehru Medical College,Aligarh Mulsim University,ALIGARH,UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
Jawaharhal Nehru Medical College |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,Uttar pradesh |
| 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 Neeraja K R |
Jawaharlal Nehru Medical College ,Aligarh Muslim University |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,Uttar pradesh
Aligarh
UTTAR PRADESH |
09048995518
kr.neeraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Faculty of Medicine,ALIGARH MUSLIM UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Prior to the induction of anaesthesia ,1mcg/kg dexmedetomididne ,diluted upto 10 ml,is given intravenously over 10 minutes. |
| Comparator Agent |
normal saline |
Prior to the induction of anaesthesia,10 ml of normal saline is administered intravenously over 10 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18-60 years
2)American Society of Anaesthesiologists (ASA) class1-2 |
|
| ExclusionCriteria |
| Details |
Physical status of ASA class III or more
Those with any significant systemic disorders
Those with uncontrolled hypertension and cerebrovascular disease
Those with co-morbid diseases liver or renal diseases
Allergy to the study drugs
Pregnant females
Preoperative bradycardia less than 55 beats per minute
Patients with known history of difficult intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| volume and dose of propofol |
when there is loss of eye lash reflex |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the time required to achieve unconsciousness in both the groups.
2.To study the haemodynamic changes in both the groups
|
when loss of eyelash reflex is noted
|
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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 Yet Recruiting |
| 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
|
A study on the effect of Dexmedetomidine on the volume and dose of Propofol required to achieve loss of consciousness using Propofol based Marsh model of target controlled infusion.
The present study will be undertaken to assess the effect of dexmedetomidine as a pre medicant on the dose and volume of the induction agent -propofol to achieve unconsciousness (loss of eyelash reflex) using Marsh model of TCI.
The secondary objectives are to compare the time required to achieve unconsciousness in both the groups and to study the haemodynamic changes in both the groups. |