| CTRI Number |
CTRI/2026/03/107212 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing Diaphragm Movement with Ultrasonography for Diagnosing Post Operative Muscle Weakness |
|
Scientific Title of Study
|
Comparison Of Diaphragmatic Excursion And Diaphragmatic Thickening Fraction As Ultrasound Markers For Assessing Post Operative Residual Curarization |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthika Sivaprakash |
| Designation |
Post Graduate |
| Affiliation |
Melmaruvathur Adhiparasakthi Institue Of Medical Sciences and Research |
| Address |
Melmaruvathur Adhiparasakthi Institue Of Medical Sciences and Research
Chennai
TAMIL NADU
603319
India |
| Phone |
9944105492 |
| Fax |
|
| Email |
karthi43@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Keerthana V |
| Designation |
Assistant Professor |
| Affiliation |
Tamil Nadu Dr. MGR Medical University |
| Address |
Melmaruvathur Adhiparasakthi Institue Of Medical Sciences and Research
Chennai
TAMIL NADU
603319
India |
| Phone |
|
| Fax |
|
| Email |
vkeerthana01994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthika Sivaprakash |
| Designation |
Post Graduate |
| Affiliation |
Melmaruvathur Adhiparasakthi Institue Of Medical Sciences and Research |
| Address |
Melmaruvathur Adhiparasakthi Institue Of Medical Sciences and Research
Chennai
TAMIL NADU
603319
India |
| Phone |
9944105492 |
| Fax |
|
| Email |
karthi43@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Chengalpattu, Tamil Nadu- 603319, India. |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Adhiparasakthi Institute Of Medical Sciences and Research |
| Address |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Chengalpattu, Tamil Nadu- 603319, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karthika Sivaprakash |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
Department of Anaesthesiology/ First floor/ Operating Theatre complex
Chennai
TAMIL NADU |
9944105492
karthi43@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research (MAPIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18–75 years.
2. American Society of Anesthesiologists (ASA) physical status I, II and III.
3. Patients undergoing elective surgery under general anaesthesia with non-depolarizing neuromuscular blocking agents.
4. Patients planned for extubation in the operating room.
5. Patients providing written informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
Patients with known neuromuscular disorders or diaphragmatic dysfunction
Body mass index more than 40 kg per meter square
Patients undergoing thoracic or upper abdominal surgery
Patients requiring postoperative mechanical ventilation
Patients in whom adequate diaphragmatic ultrasound images cannot be obtained |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy between Diaphragmatic Excursion(DE) and Diaphragmatic Thickening Fraction(DTF) in determining Postoperative residual curarization. |
DE and DTF will be measured at 4 timepoints, T1(first timepoint)- before induction of general anaesthesia, T2(second timepoint)- at reversal drug injection, T3(third timepoint)- 2minutes after extubation, T4(fourth timepoint)- 30minutes after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the correlation between ultrasound parameters & Train of Four (rTOF) ratios.
2.To evaluate the relationship between ultrasound findings & clinical respiratory outcomes |
at 4 timepoints, T1(first timepoint)- before induction of general anaesthesia, T2(second timepoint)- at reversal drug injection, T3(third timepoint)- 2minutes after extubation, T4(fourth timepoint)- 30minutes after extubation. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/03/2026 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Postoperative residual curarization (PORC), defined as a train-of-four (TOF) ratio less 0.9, is associated with postoperative respiratory complications such as hypoxia, airway obstruction, and impaired airway reflexes. Although TOF monitoring is considered the gold standard for assessing recovery from neuromuscular blockade, its use may have practical limitations. Diaphragm ultrasonography is a non-invasive bedside modality that can assess diaphragmatic function using parameters such as diaphragmatic excursion (DE) and diaphragmatic thickening fraction (DTF). This prospective observational study will include 70 adult patients undergoing elective surgery under general anaesthesia with non-depolarizing neuromuscular blocking agents. Diaphragmatic excursion and thickening fraction will be measured using ultrasonography at predefined perioperative time points and correlated with TOF ratios to evaluate their utility in detecting postoperative residual curarization. |