| CTRI Number |
CTRI/2024/09/073321 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare Sugammadex with Neostigmine for respiratory muscle strength recovery after neuromuscular blockade |
|
Scientific Title of Study
|
Comparison Of Sugammadex With Neostigmine For Respiratory Muscle Strength Recovery After Neuromuscular Blockade |
| 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 Richa Jain |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
Department of Anaesthesia |
| Address |
Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India |
| Phone |
9815068242 |
| Fax |
|
| Email |
richajain2105@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chaahat Sharma |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Department of Anaesthesia |
| Address |
Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India |
| Phone |
9815799085 |
| Fax |
|
| Email |
sharmachaahat012@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chaahat Sharma |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Department of Anaesthesia |
| Address |
Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Department of Anaesthesia
Dayanand Medical college and Hospital
Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India |
| Phone |
9815799085 |
| Fax |
|
| Email |
sharmachaahat012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital
Tagore Nagar , Civil Lines , Ludhiana
Punjab , India 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil Lines , Ludhiana, 141001 Punjab India |
| Type of Sponsor |
Private 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 |
| Dr Richa Jain |
Dayanand Medical College and Hospital |
Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar , Civil Lines Ludhiana Ludhiana PUNJAB |
9815068242
richajain2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee , Dayanand Medical College And Hospital |
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 |
| Comparator Agent |
Neostigmine |
Patients will receive neostigmine 0.05mg/kg and 0.01mg/kg glycopyrrolate as reversal agent at the end of surgery. |
| Intervention |
Sugammadex |
Patients will receive sugammadex 2 mg/kg at the end of Surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for microlaryngeal surgeries.
2. Age - 18 to 65 years.
3. American Society of Anaesthesiologists (ASA) Physical Status Grade I-III
4. Either gender |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. BMI more than 35kg/m2
3. History of allergy to drugs used in study
4. Patient with severe liver (Child Pugh B or C class), renal (stage 4 kidney disease or higher), cardiac disease and/or rhythm disorder
5. Patient requiring postoperative reintubation, tracheostomy or mechanical ventilation.
6. Known or suspected neuromuscular disease
7. Patient’s refusal to participate in the 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 |
| The change in diaphragm excursion from baseline (before induction of anaesthesia) to postextubation in both the groups. |
Post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 The change in diaphragm excursion from baseline to at 30 minutes in PACU in both the groups
2 The change in thickening fraction of internal oblique from baseline to post extubation & at 30 minutes in PACU in both the groups
3 The number of patients in whom diaphragm excursion & thickening fraction of internal oblique recovered to baseline level at post extubation & at 30 minutes in PACU in both the groups |
Before Induction, Post extubation & at 30 min in PACU |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="6" Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
Introduction: Use of neuromuscular blocking agents in general anaesthesia has been linked to postoperative residual curarization (PORC) which is associated with various postoperative pulmonary complications.Ultrasonography can be used as an alternative to acceleromyography for the assessment of PORC. Sugammadex is reported to provide more complete and faster reversal of rocuronium based neuromuscular blockade in comparison to neostigmine. Aim of Study: To compare the recovery of respiratory muscle strength using ultrasonography after reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine in the post extubation period. Materials & methods: A prospective randomized double blinded study will be conducted on 50 adult patients posted for microlaryngeal surgery under general anaesthesia after obtaining a written informed consent. Enrolled patients will be randomly divided into two equal groups to receive either sugammadex 2mg/kg or neostigmine 0.05mg/kg with glycopyrolate 0.01 mg/kg as reversal agent at end of surgery. Ultrasonography will be performed to measure diaphragm excursion (DIA) and thickening fraction of internal oblique muscle (TFIO) before induction of anaesthesia (baseline level), postextubation at train of four ratio (TOFR) ≥ 0.9 in the OR, and at 30 minutes in the PACU. Outcomes of the study are change in DIA and change in TFIO from baseline to postextubation (at TOFR ≥ 0.9) and from baseline to 30 minutes in the PACUin both the groups. The data thus collected will be statistically analysed. Clinical Significance: Residual neuromuscular blockade is prevalent but often underdiagnosed, therefore adequate prevention is necessary for better outcomes and lesser complications. Adequate reversal of the effect of muscle relaxants and assessment of muscle strength recovery in the postanaesthesia period is essential to avoid residual neuromuscular blockade. |