| CTRI Number |
CTRI/2025/08/092546 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of neuromuscular blockade on post operative diaphragmatic function |
|
Scientific Title of Study
|
Effect of shallow vs moderate neuromuscular blockade in major abdominal surgeries on post operative diaphragmatic function- a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arju Choudhary |
| Designation |
Junior resident (MD) |
| Affiliation |
AIIMS New Delhi |
| Address |
5011, 5th floor, Anaesthesia office, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
6378333477 |
| Fax |
|
| Email |
arjupradhansingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
5014, 5th floor, Anaesthesia office, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arju Choudhary |
| Designation |
Junior resident (MD) |
| Affiliation |
AIIMS New Delhi |
| Address |
5011, 5th floor, Anaesthesia office, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
6378333477 |
| Fax |
|
| Email |
arjupradhansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
5014,5th floor Anaesthesia office, AIIMS New Delhi
|
| 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 |
| Arju Choudhary |
All India Institute of Medical Sciences, New Delhi |
Main OT block, AIIMS New Delhi
New Delhi
DELHI |
6378333477
arjupradhansingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, (4) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (5) ICD-10 Condition: K55-K64||Other diseases of intestines, (6) ICD-10 Condition: K35-K38||Diseases of appendix, (7) ICD-10 Condition: K42||Umbilical hernia, (8) ICD-10 Condition: K43||Ventral hernia, (9) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, (10) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (11) ICD-10 Condition: K70-K77||Diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Application of Moderate neuromuscular blockade in major abdominal surgeries |
•Preoperative Diaphragmatic thickness fraction will be recorded
• Induction dose of Atracurium will be given
• moderate neuromuscular blockade will be maintained by infusion of Atracurium(0.2 mg /kg/hr)throughout the surgery
• Post operative diaphragmatic thickness fraction will be recorded |
| Intervention |
Application of shallow neuromuscular blockade in major abdominal surgeries. |
•Pre operative diaphragmatic thickness fraction will be monitored
•Induction dose of Atracurium will be given
•Shallow neuromuscular blockade will be maintained by infusion of Atracurium(0.1mg/kg/hour )throughout the surgery
• Post operative diaphragmatic thickness fraction will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing major abdominal surgery with an expected duration of at least 2 hours. |
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of shallow vs moderate neuromuscular blockade on post operative diaphragmatic thickness fraction 60 minutes after extubation in patients undergoing major abdominal surgery with an expected duration of at least 2 hours. |
To compare the effect of shallow vs moderate neuromuscular blockade on post operative diaphragmatic thickness fraction 60 minutes after extubation in patients undergoing major abdominal surgery with an expected duration of at least 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the the effect of shallow vs moderate neuromuscular blockade on post operative lung ultrasound score & DE |
60 minutes after extubation |
| To assess the incidence of POPC |
POD 3 |
| To assess patient centred outcomes like duration of ICU stay and hospital stay |
Post operative Hospital stay |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
16/08/2025 |
| 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="2"
Months="0"
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
|
Neuromuscular blockade is a crucial pillar of GA. Recent evidence recommends moderate level of blockade for most surgical procedures causing patient immobility without deep muscle paralysis. The multi-centered POPULAR observational study suggests that use of neuromuscular blocking agents were associated with post operative pulmonary complications. Previous studies have compared deep vs moderate neuromuscular blockade in laparoscopic surgeries, demonstrating benefits of better operating conditions along with better post operative pain scores in deep block in long duration of surgeries. A recent prospective observational study has demonstrated that a lower diaphragmatic thickness fraction was associated with postoperative pulmonary complications. We therefore aim to assess the hypothesis that shallow neuromuscular blockade as compared to moderate blockade will improve diaphragmatic function and reduce POPC. |