| CTRI Number |
CTRI/2025/11/098216 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| 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 see whether Suggamadex or neostigmine reverses pupil functions better post surgery under general anaesthesia |
|
Scientific Title of Study
|
To compare the effect of neostigmine and sugammadex on postoperative pupillary function in patients undergoing an elective surgical procedure under general anesthesia a 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 |
Sarthak Pal |
| Designation |
Junior Resident |
| Affiliation |
Post graduate institute of medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and intensive care PGIMER CHANDIGARH Chandigarh 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
6290950791 |
| Fax |
|
| Email |
sarthakpalsphs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amarjyoti Hazarika |
| Designation |
Additional Professor |
| Affiliation |
Post graduate institute of medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and intensive care PGIMER CHANDIGARH Chandigarh 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
9990238972 |
| Fax |
|
| Email |
amarjyoti28@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amarjyoti Hazarika |
| Designation |
Additional Professor |
| Affiliation |
Post graduate institute of medical Education and Research,Chandigarh |
| Address |
Department of Anaesthesia and intensive care PGIMER CHANDIGARH Chandigarh 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
9990238972 |
| Fax |
|
| Email |
amarjyoti28@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical Education and Research Chandigarh |
|
|
Primary Sponsor
|
| Name |
Sarthak pal |
| Address |
Depth of anaesthesia and intensive care, PGIMER Chandigarh.,Chandigarh 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amarjyoti hazarika |
Elective operation theatres of PGIMER Chandigarh |
Pgimer chandigarh,sector 12 , chandigarh 160012 Chandigarh CHANDIGARH |
9990238972
amarjyoti28@rediffmail.com |
| Amarjyoti Hazarika |
Post graduate institute of medical Education and Research Chandigarh |
Sector 12 Chandigarh 160012 Chandigarh CHANDIGARH |
9990238972
amarjyoti28@rediffmail.com |
|
|
Details of Ethics Committee
|
| 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 |
| Healthy Human Volunteers |
To see whether there is a difference in pupillary size and reflex post extubation when reversed with neostigmine or suggamadex |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reversal with neostigmine |
Patients will be randomised and reversed with neostigmine and their post operative pupillary size checked with a pupillometer |
| Comparator Agent |
Reversal with suggamadex |
Patients will be randomised and reversed with suggamadex and their postoperative pupillary size checked with the pupillometer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA1 and ASA2 patient undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
Patients undergoing neurological or ophthalmic surgery on any cardiac medications |
|
|
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 |
| Comparing the pupillary size 20 minutes post reversal |
20 minutes post reversal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the pupillary reactivity 20 minutes post reversal |
20 minutes post reversal |
| Comparing the size with preinduction and 1 hour post relaxant values |
|
| Comparing the incidence of PONV in both groups |
|
| Comparing the incidence of adverse events(hypotension,bradyarrythmias tachyarrythmias respiratory difficulties)in both groups |
|
|
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The use of neuromuscular blocking agents (NMBAs) is integral to modern general anesthesia, facilitating tracheal intubation, optimizing surgical conditions, and ensuring patient immobility. However, the residual function of these agents leads to compromised upper airway function, increased risk of aspiration, and delayed recovery. Reversal agents thus play a crucial role in mitigating the residual effects of these agents and enhancing patient recovery and well-being. Neostigmine, an acetylcholinesterase inhibitor, has been the traditional reversal agent of choice. It acts by increasing acetylcholine levels at the synapse, thus facilitating skeletal muscle function reversal. However, the increased acetylcholine levels in other places lead to side effects like bradycardia, bronchoconstriction, and sialorrhoea. To counteract them, an anticholinergic agent like glycopyrrolate or atropine is co-administered. However, they themselves have their side effects of tachycardia, drying of secretions, and gastric paresis. Sugammadex, a modified cyclodextrin, is a newer reversal agent. By encapsulating steroidal NMBAs such as vecuronium and rocuronium, it facilitates their rapid clearance from the body. Studies have shown that reversal using sugammadex is associated with lesser residual paralysis and hence faster recovery. Also, it is devoid of the cholinergic or anticholinergic side effects that coadministration of neostigmine and glycopyrrolate is associated with . While the systemic side effects of these reversal agents are well documented, there has not been adequate research on their effects on pupils. Pupillary functions are reflective of autonomic nervous system activity, and alterations in their size indicate underlying pharmacological effects or complications. Understanding how neostigmine or sugammadex affects pupil size and function can offer us an insight into bettering postoperative monitoring and assessing patient cognitive functions through scores like the FOUR or GCSP score, both of which use pupillary function as a component. As far as sugammadex is concerned, though it is well tolerated, it is not devoid of side effects. Side effects such as bradycardia, hypotension, and even anaphylaxis have been associated with sugammadex. Prompt recognition of these side effects is essential for optimum management and patient well being. This thesis aims to compare the effects of neostigmine and sugammadex on postoperative pupillary function in patients undergoing elective surgery under general anesthesia. By elucidating the differential impacts of these agents, the study seeks to better our understanding of the physiological effects of these agents and contribute to optimizing perioperative care, especially in settings like neurosurgical cases where the assessment of postoperative pupillary function is of importance, with it being a part of several cognitive assessment scores like GCS-P and FOUR score. |