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CTRI Number  CTRI/2025/11/097736 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational Method comparison study 
Study Design  Other 
Public Title of Study   Assessing Muscle Recovery After Anaesthesia: Train-of-Four vs Diaphragm Ultrasound 
Scientific Title of Study   Accuracy of train of four ratio and ultrasound derived diaphragm excursion as an indicator of reversal of 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)
Modification(s)  
Name  Dr.Jyoti Pathania  
Designation  Professor and Head  
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  2062-B Department of Anaesthesia, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9418120659  
Fax    
Email  pathaniajyoti7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Jyoti Pathania 
Designation  Professor and Head 
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  2062-B Department of Anaesthesia, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9418120659  
Fax    
Email  pathaniajyoti7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harman Preet Singh Kalra 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  2062-B Department of Anaesthesia, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly


UTTAR PRADESH
243006
India 
Phone  8708279933  
Fax    
Email  drharmanpreetsinghkalra@gmail.com  
 
Source of Monetary or Material Support  
Rohilkahnd Medical College and Hospital, Bareilly  
 
Primary Sponsor  
Name  Harman Preet Singh Kalra  
Address  Room No.64, Intern Boys Hostel, Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly 243006 
Type of Sponsor  Other [Self] 
 
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 Jyoti Pathania  Operation Theatre  Rohilkhand medical college and hospital,Pilibhit Bypass road, Bareilly, 234006
Bareilly
UTTAR PRADESH 
9418120659

pathaniajyoti7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, RMCH, BAREILLY, UP  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgeries under general anaesthesia.
2.ASA grades I and II. 
 
ExclusionCriteria 
Details  1.Surgical procedures performed in critical or urgent situations.
2.Patients with pre existing pulmonary diseases.
3.Patients with phrenic nerve paralysis.
4.Patients with Neuromuscular disorders such as Myasthenia Gravis etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine accuracy of train of four ratio and ultrasound derived diaphragm excursion as an indicator of reversal of neuromuscular blockade.  The TOF will be calculated at the baseline before induction and before extubation when spontaneous respiration returns. The diaphragm excursion will be measured as the vertical movement of the right hemidiaphragm during quiet spontaneous breathing, before the induction of the patient and before extubation, on return of spontaneous respiration and in the post operative room at different times (15 mins, 30 mins, 45 mins).  
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess reversal of neuromuscular blockade at the end of surgery by these two methods
2.To determine the prevalence of postoperative respiratory complications (PORC) if any in the immediate postoperative period.
3.To observe for any persistence of NM blockade after use of neostigmine in patients by measuring the diaphragmatic excursion at baseline, prior to extubation of the patient, at 10 mins in the PACU, at 15 mins & at 30 mins in the PACU.
 
Diaphragmatic Excursion to be measured at baseline, prior to the extubation, at 10 mins in the PACU, at 15 mins in the PACU & at 30 mins in the PACU. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/11/2025 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pathaniajyoti7@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

General anaesthesia commonly involves the use of neuromuscular blocking drugs, but residual neuromuscular paralysis in the postoperative period remains a significant cause of morbidity and mortality. Traditional qualitative assessments such as sustained head lift and hand grip are unreliable, with studies showing up to 60 percent of patients experiencing postoperative residual curarization . The 2023 ASA guidelines emphasize that clinical assessment alone is insufficient, recommending quantitative monitoring such as the Train-of-Four ratio, with a TOF more than or equal to 0.9 indicating adequate recovery. However, TOF monitoring has limitations, including the need for specialized equipment, baseline calibration, and patient discomfort.

Ultrasound of the diaphragm has recently gained attention as a non-invasive, real-time tool to assess diaphragmatic function through parameters such as diaphragmatic excursion, which reflects contractility and strength. Neostigmine, the most commonly used reversal agent, can variably affect diaphragmatic performance, and inappropriate dosing may paradoxically worsen muscle weakness.

This study aims to evaluate the feasibility and accuracy of ultrasound-derived diaphragmatic excursion as a surrogate marker for assessing neuromuscular recovery compared with the gold-standard TOF ratio. By correlating ultrasound findings with TOF values following neostigmine reversal 0.04 mg per kg. The study seeks to determine whether diaphragmatic ultrasound can serve as a practical, reliable, and less painful alternative for predicting residual neuromuscular blockade and guiding safe extubation, ultimately improving postoperative respiratory outcomes.

 
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