| CTRI Number |
CTRI/2025/02/081393 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| 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
|
STUDY OF EFFICACY OF DEXMEDETOMIDINE INFUSION INTRAOPERATIVE ON EMERGENCE AGITATION AND QUALITY OF RECOVERY AFTER GENERAL ANESTHESIA: A RANDOMISED CASE CONTROL STUDY |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF DEXMEDETOMIDINE INFUSION INTRAOPERATIVE ON EMERGENCE AGITATION AND QUALITY OF RECOVERY AFTER GENERAL ANESTHESIA: A RANDOMISED CASE CONTROL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi bhole |
| Designation |
Junior Resident -2 |
| Affiliation |
Grant Goverment Medical College |
| Address |
300 resident room no 737 seventh floor, junior resident -2,depatment of anaesthesia,grant medical college and jj hospital,byculla
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9511852644 |
| Fax |
|
| Email |
rashmibhole2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukriti Atram |
| Designation |
Associate professor |
| Affiliation |
Grant Goverment Medical College |
| Address |
Depatment of Anaesthesia Grant medical college and JJBhospital,byculla ,Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukriti Atram |
| Designation |
associate professor |
| Affiliation |
jj group of hospitals |
| Address |
grant medical college,jj hospital,byculla
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL ,BYCULLA,MUMBAI 400008 |
|
|
Primary Sponsor
|
| Name |
Rashmi Bhole |
| Address |
department of anaesthesiology,
grant government medical college, byculla,mumbai-400008 |
| 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 RASHMI BHOLE |
DEPARTMENT OF ANAESTHESIOLOGY |
6TH FLOOR
MAIN BUILDING
GRANT GOVERNMENT MEDICAL COLLEGE
SIR JJ GROUP OF HOSPITAL
JJ MARG
BYCULLA
MUMBAI 400008
Mumbai
MAHARASHTRA |
9511852644
rashmibhole2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF ETHICS COMMITEE,GRANT GOVERNMENT MEDICAL COLLEGE,MUMBAI,400008 |
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 |
ADMINISTRATION OF INJECTION DEXMEDITOMEDINE INFUSION (GROUP-A) |
INJECTION DEXMEDITOMEDINE OF 200UG/2ML WILL BE DILUTED WITH NORMAL SALINE 48ML TO A CONCENTRATION OF 4UG/ML IN 50 ML OF NORMAL SALINE GIVEN AT A RATE OF 0.4 UG/KG/HR AFTER INDUCTION OF ANAESTHESIA UNTIL EXTUBATION.
EMERGENCE IS DEFINED AS TIME INTERVAL FROM TIME ZERO TO TWO MINUTES AFTER EXTUBATION. DURING EMERGENCE, LEVEL OF AGITATION WILL BE EVALUATED USING RICKER SEDATION AGITATION SCALE .QUALITY OF RECOVERY WILL BE ASSESSED 24 HOURS AFTER SURGERY USING 40 ITEM QUALITY OF RECOVERY QUESTIONNAIRE. |
| Comparator Agent |
ADMINISTRATION OF VOLUME MATCHED INJECTION NORMAL SALINE INFUSION (GROUP-B) |
PATIENTS WILL RECEIVE VOLUME MATCHED INECTION NORMAL SALINE INFUSION AT THE RATE OF 0.4UG/KG/HR AFTER INDUCTION TILL EXTUBATION.
EMERGENCE IS DEFINED AS TIME INTERVAL FROM TIME ZERO TO TWO MINUTES AFTER EXTUBATION. DURING EMERGENCE, LEVEL OF AGITATION WILL BE EVALUATED USING RICKER SEDATION AGITATION SCALE .QUALITY OF RECOVERY WILL BE ASSESSED 24 HOURS AFTER SURGERY USING 40 ITEM QUALITY OF RECOVERY QUESTIONNAIRE. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA Grade 1&2 patients
2) patients underwent general anaesthesia
3)patients who have not given consent |
|
| ExclusionCriteria |
| Details |
1)known or suspected allergy to alpha 2 adrenergic agonist
2)History of uncontrolled hypertension
3)Heart block greater than first degree
4)cognitive impairement
5)Chronic use of antipsychotics
6)Kidney or liver disease and body mass index more than equal to 30 kg/m2
7)Patients who have not given consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ta assess reduction of emergence agitation onset in patients underwent general anaesthesia |
160 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)to compare the efficacy of drugs
2) to assess quality of recovery in patients
3)to assess the hemodynamic parameters
4)to look for any complications |
160 minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
03/03/2025 |
| 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="7"
Days="7" |
|
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
|
This study is to compare efficacy of dexmeditomedine infusion intraoperatively on emergence agitation and quality of recovery after general anaesthesia and it is a randomised case control study. The primary objective is to assess reduction of emergence agitation onset in patients underwent general anaesthesia and secondary objectives are to compare the efficacy of drugs ,to assess quality of recovery in patients,to assess hemodynamic parameters and to look for any complications. |