| CTRI Number |
CTRI/2026/03/106125 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two medicines (Sugammadex vs. Neostigmine) to see which works better and faster at stopping the effects of a muscle relaxant drug in adults having planned surgery |
|
Scientific Title of Study
|
EFFICACY OF SUGAMMADEX VERSUS NEOSTIGMINE FOR REVERSAL OF ROCURONIUM-INDUCED NEUROMUSCULAR BLOCKADE IN ADULTS UNDERGOING ELECTIVE SURGERY: A RANDOMISED 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 |
Abhjit Singh Pahwa |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology, Pain and Perioperative Medicin |
| Address |
Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.
Central DELHI 110060 India |
| Phone |
9650140022 |
| Fax |
|
| Email |
drabhjit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Abhjit Singh Pahwa |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology, Pain and Perioperative Medicin |
| Address |
Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.
Central DELHI 110060 India |
| Phone |
9650140022 |
| Fax |
|
| Email |
drabhjit@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Thangasiva P |
| Designation |
DNB Postgraduate Trainee |
| Affiliation |
Institute of Anaesthesiology, Pain and Perioperative |
| Address |
Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.
Central DELHI 110060 India |
| Phone |
9677201131 |
| Fax |
|
| Email |
goldsivawillwin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, 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 Abhjit Singh Pahwa |
Sir Ganga Ram Hospital |
OT11 7TH FLOOR SSRB BLOCK institute of anaesthesiology pain and perioperative medicine SGRH new delhi Central DELHI |
96501 40022
drabhjit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SGRH |
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 |
| Intervention |
NA |
NA |
| Comparator Agent |
Neostigmine group |
At the end of surgery, neuromuscular blockade will be reversed using neostigmine 50 microgram/kg (mcg/kg) along with glycopyrrolate 10 mcg/kg body weight (a premixed colourless drug in a 5ml ampoule contains 2.5mg of neostigmine and 0.5 mg of glycopyrrolate) when the neuromuscular monitor indicates a train-of-four count of 3. |
| Comparator Agent |
Sugammadex group |
At the end of surgery, neuromuscular blockade will be reversed using sugammadex 2 mg/kg body weight (2ml vial contains 100mg/ml of drug which is colourless) when the neuromuscular monitor indicates a train-of-four count of 3. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Duration of surgery is less than 2 hours |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate in the study
Patients with known neuromuscular disorders
Patients undergoing organ transplant surgery emergency procedures and patients needing intensive care admission in the postoperative period
Obese patients with a body mass index BMI greater than 30kg/m2
Renal or hepatic dysfunction
Women taking oral contraceptives
Pregnant patients
Allergy to drugs under 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 |
| Time required to achieve the quantitative neuromuscular monitoring endpoint (TOFR 0.9) following the administration of the reversal agents under investigation |
At time of giving reversal agent
When TOFR reached 0.9
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
patients having bronchospasm, tachypnea with respiratory rate greater than 24 per min, SpO2 less than 92 % at room air during the first 60 min after extubation, in the PACU.
patients requiring airway support (viz. airway opening manoeuvres, oral or nasal airway insertion, CPAP / BiPAP, endotracheal intubation) during the first 60 min after extubation, in the PACU.
patients having heart rate greater than 100/min or less than 60/min, systolic blood pressure plus minus 20% of baseline, diastolic blood pressure plus minus 20% of baseline, and mean blood pressure plus minus 20% of baseline, after administration of reversal agent, continuing to PACU for the first 60 min post-extubation.
|
till 60 mins after extubation |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
17/03/2028 |
| 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
|
Reversal of neuromuscular blockade
(NMB) is essential for optimal recovery following general anaesthesia. Neostigmine
has long served as the conventional agent for this purpose; however, sugammadex
a novel cyclodextrin compound specifically engineered to counteract
rocuronium-induced NMB has demonstrated promising advantages in terms of speed
and reliability. Although both agents facilitate reversal of rocuronium, their
comparative efficacy and safety profiles remain subjects of ongoing clinical
scrutiny, particularly when assessed using train-of-four (TOF) neuromuscular
monitoring.
This randomized controlled trial is designed to
evaluate the efficacy of sugammadex versus neostigmine for reversing rocuronium-induced NMB in adult patients
undergoing elective surgical procedures under general anaesthesia. TOF
monitoring will be employed to ensure objective and quantifiable assessment of
efficacy of neuromuscular recovery as determined by the time to achieve the
primary outcome.
A total of 100 adult patients who
meet eligibility criteria and provide informed consent will be enrolled. The primary
outcome is the time required to achieve a TOF ratio (TOFR) of gretaer than 0.9 after administration of reversal agent. Secondary
outcomes include the incidence of adverse respiratory events in the
post-anaesthesia care unit (PACU) till 60 minutes after extubation, as well as
perioperative changes in hemodynamic parameters, namely, heart rate (HR),
systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean
arterial pressure (MAP).
While international literature
consistently supports the superior efficacy of sugammadex over neostigmine in
reversing rocuronium-induced NMB, to the
best of our knowledge, there is no study in the Indian population. To address
this gap, our study seeks to generate contextually relevant evidence. |