| CTRI Number |
CTRI/2025/11/097039 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two different maintenance anesthetic agents(propofol and desflurane) on postoperative cognitive dysfunction in elderly patients undergoing elective spine surgeries under general anesthesia |
|
Scientific Title of Study
|
A randomized comparative study to evaluate the effects of propofol versus desflurane on postoperative cognitive dysfunction in elderly patients undergoing elective spine surgeries under general anesthesia at Sawai Man Singh medical college Jaipur |
| 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 Neelu Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and attached hospitals |
| Address |
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9782480455 |
| Fax |
|
| Email |
drneelu13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelu Sharma |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and attached hospitals |
| Address |
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9782480455 |
| Fax |
|
| Email |
drneelu13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya J |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh medical college and attached hospitals |
| Address |
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8883529276 |
| Fax |
|
| Email |
divyajothivel@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNDY(Mukhyamantri Nishulk Dawa Yojna), Warehouse, SMS Hospital
Jaipur, Rajasthan, India
302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals Jaipur |
| Address |
Department of Anaesthesiology Sawai Man Singh medical college and attached hospitals Jaipur Rajasthan
302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Divya J |
Sawai man Singh medical college and attached hospitals Jaipur |
Department of Anaesthesiology
Neurosurgery OT complex and postoperative ward,
Sawai Man Singh medical college and attached hospitals
Jaipur
302004
Jaipur
RAJASTHAN |
8883529276
divyajothivel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics committee Sawai Man Singh medical college and attached hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desflurane as maintenance anesthetic agent |
Inhalational desflurane with the help of desflurane vaporizer as maintenance anesthesia throughout the surgery(approximately 2 hours) to maintain BIS between 40-60 |
| Intervention |
Propofol as maintenance anesthetic agent |
Intravenous propofol infusion for maintenance anesthesia throughout the surgery(approximately 2 hours) at the rate of 100-200mcg/kg/min to maintain BIS between 40-60 |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are all scheduled for elective spine surgeries
2. Patients giving informed written consent to the study
3. Patients of age more than 60 years
4. Patients belonging to American Society of Anaesthesiologists class 1, 2 and 3 |
|
| ExclusionCriteria |
| Details |
1. Known case of psychiatric diseases and cognitive dysfunction
2. Patients with a history of drug abuse
3. Postoperative intubated or tracheostomized after one week of surgery
4. Patients who are unable to comprehend the questionnaire
5. Patients with a history of multiple previous surgeries
6. Patients should not be a part of any other study |
|
|
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 |
| Mean POCD (Post Operative Cognitive Dysfunction) Score |
1 Week after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of POCD
2. Mean score in various domains of cognitive function(Executive, Naming, Attention, Language, Abstraction, Recall, Orientation)
3. Mean hemodynamic parameters(HR, SBP, DBP, MBP) |
1. 1 week after the surgery
2. 1 week after the surgery
3. 0, 10, 30, 60, 120 min |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Postoperative Cognitive Dysfunction refers to a condition where patients experience a decline in cognitive function after undergoing surgery. This decline can manifest as problems with memory, attention, concentration, and overall cognitive abilities. POCD is particularly observed in elderly patients, although it can also affect younger individuals. The duration of POCD can vary from a few days to several weeks or months post-surgery. Among the various factors influencing POCD, the choice of anaesthetic agents has garnered considerable attention in recent research. Use of intravenous and inhalational anaesthetic agents as maintenance anaesthesia have been extensively studied in relation to Postoperative Cognitive Dysfunction (POCD), reflecting their widespread use in surgical procedures and potential impact on cognitive function. In this study, we prospectively evaluate the effects of propofol versus desflurane on Post Operative Cognitive Dysfunction in elderly patients undergoing elective spine surgeries. This study will be conducted in two groups(Group A and Group B). Each group consists of 75 patients. Group A patients will receive propofol as maintenance anaesthetic agent and Group B patients will receive desflurane as maintenance anaesthetic agent. Patient will be identified, PAC will be checked, MOCA(Montreal Cognitive Assessment) test will be done to get pre operative MOCA score, informed written consent will be taken and patient will be taken inside the OT. Pre-operative vitals (PR, NIBP, ECG, SpO2) will be recorded. IV fluids will be started through already secured IV line as per hospital protocol.Premedication will be given with Inj. Midazolam 0.05mg/kg IV, Inj. Glycopyrrolate 0.005mg/kg IV, Inj. Fentanyl 2 µg/kg IV. Patient will be induced with Inj. Thiopentone(5-7mg/kg) IV + Inj. Rocuronium(0.6-1.2mg/kg) IV. Airway will be secured with Endotracheal Tube of appropriate size. Group A (N= 75) patients will receive propofol 50-200mcg/kg/min as maintenance anaesthesia along with N2O:O2(50:50) titrated to maintain BIS score between 40-60. Group B(N=75) patients will receive desflurane 2.5-8.5% as maintenance anaesthesia along with N2O:O2(50:50) titrated to maintain BIS score between 40-60. Hemodynamic parameters will be recorded throughout the surgery at fixed intervals. At the end of surgery, patient will be reversed with Inj. Neostigmine 0.06mg/kg and Inj. Glycopyrrolate 0.001mg/kg IV. Patient will be extubated after the patient is satisfying extubation criteria. Additionally, 4 mg of ondansetron will be administered to prevent postoperative nausea and vomiting and patients will be transferred to the post-anaesthesia care unit (PACU). Data collection after one week of surgery using MOCA(Montreal Cognitive Assessment) Score will be done and recording incidence of POCD, mean POCD score and score in various domains of cognitive function.
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