| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pathaniajyoti7@gmail.com].
- 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.
- 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. |