| CTRI Number |
CTRI/2026/04/107256 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two drugs used after anesthesia to reduce mental confusion in elderly patients after surgery. |
|
Scientific Title of Study
|
Comparison of the Effect of Sugammadex and Neostigmine on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Elective Surgery Under General Anesthesia- A Prospective, Randomized, Controlled Study |
| 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 Arjun Prasad Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and critical care, 2nd floor, Institute block, JIPMER Campus, Dhanvantari Nagar, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7050659442 |
| Fax |
|
| Email |
aschaudhary1402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banupriya R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and critical care, 2nd floor, Institute block, JIPMER Campus, Dhanvantari Nagar, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9677629587 |
| Fax |
|
| Email |
banupriya147@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Prasad Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anesthesiology and critical care, 2nd floor, Institute block, JIPMER Campus, Dhanvantari Nagar, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7050659442 |
| Fax |
|
| Email |
aschaudhary1402@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arjun Prasad Chaudhary |
Jawaharlal Institute of Postgradute Medical Education and Research |
Department of Anaesthesiology and Critical Care, 2nd floor, Institute block, Grimed, Dhanvantari Nagar, Pondicherry, 605006
Pondicherry
PONDICHERRY |
7050659442
aschaudhary1402@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES,JIPMER,PUDUCHERRY |
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 |
Intravenous Neostigmine |
At the end of surgery, inj. neostigmine 50 mcg/kg with inj glycopyrrolate 10 mcg/kg will be administered when TOF ratio is less than 0.4 and patient will be extubated when TOF ratio is more than 0.9.TOF recovery time, extubation time will be recorded. Patients cognitive status and quality of recovery will be assessed using MoCA,MMSE, and QoR scores on POD 1 and MoCA on day 3. |
| Intervention |
Intravenous Sugammadex |
At the end of surgery, inj. sugammadex 2 mg/kg will be administered when TOF ratio is less than 0.4 and patient will be extubated when TOF ratio is more than 0.9.TOF recovery time, extubation time will be recorded. Patients cognitive status and quality of recovery will be assessed using MoCA,MMSE, and QoR scores on POD 1 and MoCA on day 3. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) status I-III patients undergoing elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1.Known case of dementia or preoperative (Baseline) MMSE score less than 22
2.Severe audio-visual impairments and patients unable to read or write.
3.Allergy to any of the drugs used in the study including sugammadex.
4.Congestive heart failure, liver and renal failure
5.History of stroke, cerebral surgeries, active infection, electrolyte imbalance
6.History of known psychiatric/ neurodegenerative disorder
7.Chronic opioid or substance abuse, patients on sedatives, antidepressants, and glucocorticoids
8.Patients with neuromuscular disorders
9.Patients undergoing cardiac, vascular, and neuro-surgeries
|
|
|
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 |
| To compare the cognitive function on postoperative day 1 based on Montreal Cognition Assessment Examination scores (MOCA Scores) between the groups receiving sugammadex and neostigmine to reverse neuromuscular blockade in elderly patients undergoing elective surgery under general anesthesia. |
Day 1 after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- MOCA & MMSE Scores: Preoperative Day (Baseline), POD 1 & 3 among the groups
- Extubation time
-TOF recovery time
- Incidence of PONV
- Quality of recovery (QoR-15) |
MOCA, MMSE Scores, QOR: Preoperative Day (Baseline), POD 1 & 3 among the groups |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/05/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Postoperative cognitive dysfunction following surgery under general anesthesia is a known complication particularly among elderly patients.This study compares the effectiveness of sugammadex to neostigmine in reduction of post operative cognitive dysfunction in elderly patients undergoing elective surgery under general anesthesia. 76 patients meeting inclusion criteria will be assessed one day before surgery using MoCA, MMSE, QoR15 score.On the day of surgery, patients will be randomized into two groups, the first group receiving inj. sugammadex and the other receiving ins neostigmine and glycopyrrolate as reversal for neuromuscular blockade. The primary outcome is to compare cognitive function using MoCA score on POD 1 in both the groups. Secondary outcomes include TOF recovery time, extubation time, incidence of PONV, Quality of recovery. |