| CTRI Number |
CTRI/2019/05/019456 [Registered on: 30/05/2019] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of POCD between Propofol induction and Ketofol induction |
|
Scientific Title of Study
|
Comparative evaluation of effect of propofol and ketofol induction on the incidence of postoperative cognitive dysfunction in adults undergoing general anesthesia- a double blinded randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARATH BK |
| Designation |
DNB Student |
| Affiliation |
Deen Dayal upadhyay hospital. |
| Address |
Department of Anesthesiology, Deen Dayal Upadhyay Hospital, harinagar, New Delhi 110064
West
DELHI
110064
India |
| Phone |
9844003798 |
| Fax |
|
| Email |
bkbharath3021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Babbar |
| Designation |
HOD, Department of Anesthesiology |
| Affiliation |
Deen dayal upadhyay hospital |
| Address |
Department of Anesthesiology, Deen Dayal Upadhyay Hospital, harinagar, New Delhi 110064
West
DELHI
110064
India |
| Phone |
9718990110 |
| Fax |
|
| Email |
babbarrl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHARATH BK |
| Designation |
DNB Student |
| Affiliation |
Deen Dayal upadhyay hospital. |
| Address |
Department of Anesthesiology, Deen Dayal Upadhyay Hospital, harinagar, New Delhi 110064
West
DELHI
110064
India |
| Phone |
9844003798 |
| Fax |
|
| Email |
bkbharath3021@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEEN DAYAL UPADHYAY HOSPITAL, HARINAGAR, NEWDELHI 110064 |
|
|
Primary Sponsor
|
| Name |
Deen dayal upadhyay hospital New Delhi |
| Address |
Deen dayal upadhyay hospital Harinagar New Delhi 110064 |
| Type of Sponsor |
Other [] |
|
|
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 Bharath B K |
DEEN DAYAL UPADHYAY HOSPITAL |
Department of Anesthesiology, Harinagar New Delhi 110064
West
DELHI |
9844003798
bkbharath3021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEEN DAYAL UPADHAYAY HOSPITAL ETHICAL 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 |
| Comparator Agent |
KETOFOL |
PROPOFOL AND KETAMINE, INTRAVENOUS ROUTE OF ADMINISTARTION,BOTH WILL BE USED FOR GENERAL ANESTHESIA INDUCTION. TOTAL DURATION IS LESS THAN 2 HOURS |
| Intervention |
PROPOFOL INDUCTION |
PROPOFOL, INTRAVENOUS ROUTE OF ADMINISTRATION, IS USED FOR GENERAL ANESTHESIA INDUCTION. TOTAL DURATION IS LESS THAN 2 HOURS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
SURGERY NOT EXPECTED TO CROSS 2 HOURS
EDUCATION ATLEAST 10TH STANDARD PASS |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
HISTORY OF KNOWN ALLERGY TO DRUGS BEING USED
HISTORY OF PSYCHIATRIC ILLNESS DRUG OR ALCOHOL
ABUSE AND CHRONIC PAIN
HISTORY OF TREATMENT WITH ANTIANXIETY OOPIIOD ANTICONVULSANTS AND ANTIPYSCHOTIC DRUGS
PREGNANT AND LACTATING WOMEN
PATIENT WITH HISTORY OF ALZHEIMERS DISEASE AND MMSE SCORE LESS THEN 23 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE THE INCIDENCE OF POST OPERATIVE COGNITIVEDYSFUNCTION AS PER POSITIVE NEUROPSYCHOLOGICAL TESTS IN BOTH THE GROUPS |
POST OPERATIVE 5 MINS, 30 MINS , 1 HOUR, 2 HOUR AND 4 HOUR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate Richmond agitation sedation scale wth incidence of positive neuropsychological tests for POCD.
To assess the relation of age and education on POCD in ketofol and propofol group.
To copare hemodynamic parameterrs in ketofol and propofol groups upto 4 hours postoperatively. |
Intraoperatively and 4 hours of podstoperative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2019 |
| Date of Study Completion (India) |
27/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
study completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ketamine and Propofol admixture is associated with improved hemodynamics when used as an induction agent. Postoperative cognitive dysfunction is a common adverse event after general anesthesia which represents a decline in a variey of neuropsychological domains including memory, executive functioning and speed of thought processing. Since, Ketamine has dissociativeproperties and Ketofol is being increasingly used for its hemodynamic stability profile, we decide to compare the incidence of POCD with Ketamine(0.75mg/kg) and Propofol(1.25mg/kg) combination when compared to Propofol(2mg/kg) alone for induction of general anesthesia.
A battery of neuropsychological tests will be used to assess POCD which can be debilitating in day care surgeries. Neuropsychological tests are Mini mental state examination, California verbal learning test, Digit span test, Stroop card word and colour test. |