| CTRI Number |
CTRI/2022/02/039916 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the pattern of neurocognitive recovery after general anaesthesia between two age groups |
|
Scientific Title of Study
|
Comparative study on the pattern of neurocognitive recovery after general anaesthesia between the elderly and young age population- a case control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R K DHARANI |
| Designation |
Junior resident |
| Affiliation |
sri ramachandra institute of higher education |
| Address |
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9003071027 |
| Fax |
|
| Email |
dharani.kumaresan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sree Kumar EJ |
| Designation |
Assistant professor |
| Affiliation |
sri ramachandra institute of higher education |
| Address |
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sree Kumar EJ |
| Designation |
Assistant professor |
| Affiliation |
sri ramachandra institute of higher education |
| Address |
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
8056564566 |
| Fax |
|
| Email |
sreekumardr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and pain medicine, 6th floor, Sri Ramachandra Institute of Higher Education and Research, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai. |
|
|
Primary Sponsor
|
| Name |
Dr R K DHARANI |
| Address |
Department of anaesthesiology and pain medicine, Sri Ramachandra institute of Higher Education and Research, 1, Mount poonamallee road, Porur, Chennai-600116 |
| 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 R K Dharani |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anaesthesiology and pain medicine, 6th floor, 1, Mount poonamallee road, Ramachandra nagar, Porur, Chennai.
Chennai
TAMIL NADU |
9003071027
dharani.kumaresan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Recovery in geriatric patients |
Pattern of neurocognitive recovery will be assessed in geriatric age group in the post operative period with a set of neurocognitive test in a set time period (30 minutes post extubation. Each trial lasts for 15 minutes and there is a time sapn of 30 minutes in between trials) |
| Comparator Agent |
Recovery in young age group |
Pattern of neurocognitive recovery will be assessed in young age group in the post operative period with a set of neurocognitive test in a set time period (30 minutes post extubation. Each trial lasts for 15 minutes and there is a time span of 30 minutes in between trials) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASAI-III
Elective laproscopic surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Visual and auditory impairment
Previous cerebrovascular accident
Preoperative cognitive dysfunction
Limb amputees |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time of recovery of neurocognitive function after general anesthesia between elderly and young age group |
Pre operative, 30 minutes, 1 hour, 1 hour 30 minutes and 2 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pattern of recovery among elderly age group |
Pre operative, 30 minutes, 1 hour, 1 hour 30 minutes and 2 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
10/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
YET TO SUBMIT |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a non- randomised active interventional study to find out the time taken for neurocognitive recoery in geriatric age group in comparision with the young age group. Previous studies have noted time and pattern of recovery in young adults. All patients included in the study, after informed consent undergo preoperative set of neurocognitive tests. After standardised anaesthetic management for the given surgical procedures post extubation neurocognitive test will be done at 30 minutes, 1 hour, 1 hour 30 minutes and 2 hour. Time and pattern of recovery will be noted, We postulate that time and pattern of recovery is delayed in elderly in comparision with the young age group. |