| CTRI Number |
CTRI/2022/01/039540 [Registered on: 18/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISION OF ORIENTATION CHANGES IN OLD PATIENTS FOLLOWING GENERAL ANESTHESIA USING GASES ISOFLURANE VS DESFLURANE GAS |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF POST-OPERATIVE COGNITIVE DYSFUNCTION IN ELDERLY PATIENTS FOLLOWING GENERAL ANESTHESIA USING ISOFLURANE AND DESFLURANE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr UPASANA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
3rd FLOOR , BLT BUILDING ,DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, MAULANA AZAD MEDICAL COLLEGE, 02, BAHADUR SHAH ZAFAR MARG
Central
DELHI
110002
India |
| Phone |
7982208117 |
| Fax |
|
| Email |
anesthesia.upasana.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUKHYANTI KERAI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, MAULANA AZAD MEDICAL COLLEGE, 02, BAHADUR SHAH ZAFAR MARG
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UPASANA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
3rd FLOOR , BLT BUILDING ,DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, MAULANA AZAD MEDICAL COLLEGE, 02, BAHADUR SHAH JAFAR MARG
Central
DELHI
110002
India |
| Phone |
7982208117 |
| Fax |
|
| Email |
anesthesia.upasana.2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, MAULANA AZAD MEDICAL COLLEGE, 02, BAHADUR SHAH ZAFAR MARG, NEW DELHI-110002 |
|
|
Primary Sponsor
|
| Name |
Dr UPASANA |
| Address |
DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE , MAULANA AZAD MEDICAL COLLEGE , DELHI -110002 |
| 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 UPASANA |
MAMC AND ASSOCIATED HOSPITAL |
3 rd FLOOR , BLT BUILDING DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL, NEW DELHI 110002
Central
DELHI |
7982208117
anesthesia.upasana.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
DESFLURANE |
DESFLURANE AS INHALATIONAL ANESTHETIC AGENT FOR 1-2 HRS OF SURGERY |
| Comparator Agent |
ISOFLURANE |
ISOFLURANE AS INHALATIONAL ANESTHETIC AGENT FOR 1-2 HRS OF SURGERY |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2 PATIENTS
EXPECTED DURATION OF SURGERY 1-2 HOURS
MODE OF ANAESTHESIA IS GENERAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
PATIENTS UNABLE TO COMPREHEND THE REQUIRED COGNITIVE ASSESSMENT TESTS.
HINDI MENTAL STATE EXAMINATION10 SCORE ≤ 26 PREOPERATIVELY
KNOWN CASES OF ANY PSYCHIATRIC ILLNESS.
HISTORY OF CEREBROVASCULAR ACCIDENT.
KNOWN DISORDER AFFECTING COGNITION.
KNOWN HISTORY OF ALCOHOL/DRUG ABUSE.
|
|
|
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 |
INCIDENCE OF POCD ON POSTOPERATIVE DAY 1 AS ASSESSED BY HINDI MENTAL STATE EXAMINATION(HMSE)
|
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CORELATION BETWEEN POCD WITH
1.AGE
2.DURATION OF EXPOSURE TO INHALATIONAL ANESTHESIA
3.LEVEL OF EDUCATION
|
1 day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
24/01/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 RANDOMISED CONTROL TRIAL TO COMPARE THE POST OPERATIVE COGNITIVE DYSFUNCTION IN ELDERLY PATIENTS FOLLOWING GENERAL ANESTHESIA USING ISOFLURANE AND DESFLURANE AS INHALATIONAL AGENTS . |