| CTRI Number |
CTRI/2025/11/097426 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| 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
|
To compare the effect of two drugs used to reverse the effect of drugs used to paralyse using ultrasound scan |
|
Scientific Title of Study
|
COMPARISON OF SUGAMMADEX VERSUS NEOSTIGMINE TO MEASURE RESPIRATORY MUSCLE STRENGTH RECOVERY POST-EXTUBATION IN ADULTS: 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 |
Dr Shreya S Hegde |
| Designation |
Post graduate student |
| Affiliation |
Bangalore Medical College and Research Institute. |
| Address |
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru. Bangalore KARNATAKA
Bangalore
KARNATAKA
560002
India |
| Phone |
8197264790 |
| Fax |
|
| Email |
shreyahegde19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saraswathi N |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute. |
| Address |
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru. Bangalore KARNATAKA
Bangalore
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saraswathi N |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute. |
| Address |
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru. Bangalore KARNATAKA
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, KR road,Fort, Bangalore, Karnataka, 560002 |
|
|
Primary Sponsor
|
| Name |
DrShreya S Hegde |
| Address |
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru, Karnataka, 560002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya S Hegde |
Bangalore Medical College and Research Institute. |
3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.
Bangalore
KARNATAKA |
8197264790
shreyahegde19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neostigmine and glycopyrrolate for reversal of neuromuscular blockade |
In patients undergoing abdominal surgeries under general anaesthesia, neuromuscular blockade is given with Injection vecuronium 0.1 mg/kg. Depth of NMB monitored by acceleromyography of adductor pollicis with TOF watch. At the end of surgical procedure, after TOF0.7, patients will receive injection Neostigmine 0.05 mg/kg and injection 0.01 mg/kg iv. Muscle strength recovery will be assessed with ultrasound immediately after extubation and 30 minutes after extubation. |
| Intervention |
Sugammadex for reversal of neuromuscular blockade after general anaesthesia |
In patients undergoing abdominal surgeries under general anaesthesia, neuromuscular blockade is given with Injection vecuronium 0.1 mg/kg. Depth of NMB monitored by acceleromyography of adductor pollicis with TOF watch. At the end of surgical procedure, after TOF0.7, patients will receive Inj Sugammadex 2 mg/kg iv Muscle strength recovery will be assessed with ultrasound immediately after extubation and 30 minutes after extubation.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give informed consent (ANNEXURE 1)
Patients of age 18-60 years.
ASA grade 1 & 2(ANNEXURE 2)
Patients undergoing abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiology (ASA) physical status III–IV
significant kidney disease (stage 4 kidney disease or higher)
significant liver disease (Child-Pugh B or C class)
history of chronic obstructive pulmonary disease
known or suspected neuromuscular disease
arrhythmic disease or use of antiarrhythmic drugs
allergy to rocuronium, neostigmine, or sugammadex
suspected difficult airway
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare respiratory muscle strength recovery in sugammadex and neostigmine
|
Baseline(before induction of anaesthesia), immediate post extubation, 30 minutes post extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess time taken from administration of reversal agent to extubation in sugammadex & neostigmine
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
26/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/11/2025 |
| 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 Yet Recruiting |
| 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
|
Background and aims
Residual neuromuscular blockade is a common complication after general anesthesia.Commonly used reversal agent, neostigmine, cannot reverse profound neuromuscular blockade, risking postoperative recurarization. Sugammadex, a novel reversal agent, provides complete reversal of deep neuromuscular blockade with lesser adverse effects such as residual neuromuscular blockade and pulmonary complications.
This study aims at evaluating the postoperative respiratory muscle strength recovery in Sugammadex and Neostigmine.
Method
Following institutional ethics approval and informed consent, 38 patients undergoing surgery will be randomized into two groups 19 each, to receive either sugammadex or neostigmine for neuromuscular blockade reversal. Anaesthesia will be standardized across all patients, with neuromuscular monitoring using TOF Watch. Reversal agents will be administered at TOF ratio more than 0.7, and extubation performed once TOFR more than 0.9. Respiratory muscle function including thickness fraction of internal oblique , diaphragm , intercostals , and diaphragmatic excursion will be assessed via ultrasonography at three time points, baseline, post-extubation, and 30 minutes post-extubation. Standard B-mode and M-mode ultrasound techniques will be used, with three repeated measures per muscle, recording the highest value. The study is aimed to compare the efficacy of sugammadex and neostigmine on respiratory muscle recovery post-reversal.
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