| CTRI Number |
CTRI/2025/08/092205 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the relationship between diaphragm movement and muscle response in patients having laparoscopic surgery under general anaesthesia |
|
Scientific Title of Study
|
Evaluation of correlation of diaphragmatic excursion and diaphragm thickening fraction with train of four ratio in patients undergoing laparoscopic surgeries under general anaesthesia: A prospective observational study |
| 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 Shankar Rathod |
| Designation |
Post graduate |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
Department of Anaesthesia main hospital building , SDM college of medical sciences and hospital manjushree nagar , Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7975525472 |
| Fax |
|
| Email |
shankar1998rathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana A Bharadwaj |
| Designation |
Associate professor |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
Department of Anaesthesia main hospital building , SDM college of medical sciences and hospital manjushree nagar , Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8437373388 |
| Fax |
|
| Email |
archana.a.b16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Rathod |
| Designation |
Post graduate |
| Affiliation |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
| Address |
Department of Anaesthesia main hospital building , SDM college of medical sciences and hospital manjushree nagar , Dharwad
KARNATAKA
580009
India |
| Phone |
7975525472 |
| Fax |
|
| Email |
shankar1998rathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital manjushree nagar , Dharwad |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SATTUR DHARWAD |
| Address |
Department of Anaesthesiology SDM College of Medical Sciences and Hospital, sattur Dharwad- 580009 |
| 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 |
| Shankar Rathod |
SDM college of medical sciences and hospital manjushree nagar , Dharwad |
OT complex, OT 5, 6.Department of Anaesthesia SDM college of medical sciences and hospital manjushree nagar , Dharwad
Dharwad
KARNATAKA |
7975525472
shankar1998rathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The IEC-SDM COLLEGE OF MEDICAL SCIENCES 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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex, aged 18 years and above.
2. Patients scheduled for laparoscopic surgeries. 3. ASA physical status (ASA PS) I,II and III . |
|
| ExclusionCriteria |
| Details |
1. Pre existing neuromuscular disorders.
2. Patients with existing diaphragmatic dysfunction
3. Uncontrolled hypothyroid ism, hypokalemia, hypomagnesemia , metabolic derangements
4. Patients with chronic kidney disease, hepatic dysfunction .
5. ASA PS lV or higher
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DTF AND DE AT TOFR 0.9 |
Before extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the impact of factors BMI, age and duration of surgery on DUS parameters. |
Before extubation |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
15/08/2025 |
| 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="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
|
This clinical study involves 61 patients undergoing elective laparoscopic surgeries under general anesthesia from August 15 2025 to February 15th 2026 at a tertiary care teaching hospital. After ethical approval and consent, patients will undergo preoperative evaluations including BMI, demographic data, and airway examination. On surgery day, diaphragmatic ultrasound (DUS) parameters (DE, DTF) will be recorded pre- and post-operatively. General anesthesia will be induced using IV fentanyl (2 mcg/kg) and propofol (2 mg/kg), followed by vecuronium (0.1 mg/kg) for muscle relaxation. Neuromuscular monitoring (TOF count and TOFR) will guide vecuronium dosing and extubation readiness. Post-surgery, neostigmine and glycopyrrolate will be used for reversal, and patients will be extubated once stable and awake. |