| CTRI Number |
CTRI/2025/09/095245 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between neostigmine and Sugammadex in terms of efficacy and safety as reversal agent in major surgeries under general anaesthesia |
|
Scientific Title of Study
|
comparison of neuromuscular recovery profile using neostigmine and sugammadex as reversal agents in major surgeries under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeshna Moi |
| Designation |
post graduate trainee Anaesthesiology |
| Affiliation |
I.P.G.M.E. and R. and SSKM Hospital |
| Address |
I.P.G.M.E.and R. AND SSKM HOSPITAL, Department of Anaesthesiology,244AJC Bose ROAD , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8967445160 |
| Fax |
|
| Email |
amisudeshna10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TAPAS GHOSE |
| Designation |
Professor, Department of Anaesthesiogy |
| Affiliation |
I.P.G.M.E. and R. and SSKM Hospital |
| Address |
I.P.G.M.E. and R. AND SSKM HOSPITAL, Department of Anaesthesiology,244AJC Bose ROAD , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903745071 |
| Fax |
|
| Email |
g.tapas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TAPAS GHOSE |
| Designation |
Professor, Department of Anaesthesiogy |
| Affiliation |
I.P.G.M.E. and R. and SSKM Hospital |
| Address |
I.P.G.M.E. and R. AND SSKM HOSPITAL, Department of Anaesthesiology,244AJC Bose ROAD , Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903745071 |
| Fax |
|
| Email |
g.tapas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
IPGMER AND SSKM HOSPITAL, AJC bose road, Kolkata , 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
I. P. G. M. E. and R. and SSKM Hospital, 244 AJC Bose road ,Kolkata 700020. |
| 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 |
| SUDESHNA MOI |
I. P. G. M. E. and R. and SSKM Hospital |
Department of Anaesthesiology,3rd floor,main block, 244 AJC Bose road ,Kolkata 700020.
Kolkata
WEST BENGAL |
8967445160
amisudeshna10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K911||Postgastric surgery syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Giving Neostigmine and sugammadex |
To determine the efficacy and safety of Sugammadex over Neostigmine as reversal agents in major surgeries |
| Comparator Agent |
neostigmine and sugammadex |
compare efficacy and safety between two drugs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing major surgeries with ASA PS I,II,BMI Below 30kg/m2, who gave informed consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of time between administration of reversal agent to safe tracheal extubation |
Time point between giving reversal agent to tracheal extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare quality of neuromuscular recovery, hemodynamic variables, adverse effects |
immediate post operative period |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/09/2025 |
| 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="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
|
Muscle relaxation is required for facilitation of surgery with adequate anaesthetic depth. If reversal to this muscle relaxation is not complete, it may result in pulmonary complications and delayed recovery. In this study we will compare sugammadex and neostigmine as reversal agents in terms of safety and efficacy. |