| CTRI Number |
CTRI/2025/11/096786 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
return of normal mental function after anesthesia with desflurane and sevoflurane |
|
Scientific Title of Study
|
A Study Comparing the Recovery of Cognitive Function and Airway Reflexes After Sevoflurane and Desflurane Anaesthesia in Elderly Patients: A Prospective, Randomized, Double-Blinded Trial
|
| 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 Tarique Adib |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Institute of medical sciences, Patna |
| Address |
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
Patna
BIHAR
800014
India |
| Phone |
9631361412 |
| Fax |
|
| Email |
tariquemallick98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjeet Rana De |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
Patna
BIHAR
800014
India |
| Phone |
7903696301 |
| Fax |
|
| Email |
ranjeet.igims2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjeet Rana De |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of medical sciences, Patna |
| Address |
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
IGIMS, Patna
Department of Anesthesia, Neuro Ot Complex 1-12, 1st floor, ward block 13
Patna
BIHAR
800014
India |
| Phone |
7903696301 |
| Fax |
|
| Email |
ranjeet.igims2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna
Bailey road
800014 |
|
|
Primary Sponsor
|
| Name |
Dr Tarique Adib |
| Address |
Indira Gandhi Institute of Medical Sciences, Patna
Bailey Road
800014 |
| 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 Tarique Adib |
Indira Gandhi Institute of medical sciences, Patna |
Department of Anaesthesiology, Ward block 13, 1st floor Neuro Ot Complex 1-12
Patna
BIHAR |
9631361412
tariquemallick98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee, IGIMS |
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 |
Desflurane |
Use of desflurane as inhalational anesthetics till MAC achieve 1 in 50-70 yr age individual till intraoperative period and assessment of cognitive function and airway reflexes post Anesthesia |
| Comparator Agent |
Sevoflurane |
Use of sevoflurane as inhalational anesthetics till MAC achieve 1 in 50-70 yr age individual till intraoperative period and assessment of cognitive function and airway reflexes post Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (50-70 years)
2. ASA (American Society of Anaesthesiologists) physical status
I/II/III.
3. Patients undergoing elective surgery requiring general
anaesthesia
4.Duration of surgery less than120 minutes
5.Patients able to comprehend and willing to participate |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to participate
2. History of chronic respiratory or neurological disorders
3. Known allergies or sensitivity to Sevoflurane or Desflurane
4. Pregnancy or lactation
4. Significant psychiatric history
5. Duration of surgery more than 120 minute |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Cognitive Function |
5 minutes, 15 minutes, 30 minutes, 1hours, 2hours, 4hours, 6hours, 12hours, 24hours, 48hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Airway Reflexes |
5 minutes,10 minutes,15 minutes, 30 minutes, 1 hour, 2 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/11/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tariquemallick98@gmail.com].
- For how long will this data be available start date provided 05-11-2027 and end date provided 05-11-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Conducting studies in elderly group
comparing sevoflurane and desflurane recovery profiles is essential
to generate relevant evidence, improve clinical care, and address
unique regional healthcare challenges. This will help bridge the
current knowledge gap and support anaesthesia practice tailored to
the needs of elderly patients. |