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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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