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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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