| CTRI Number |
CTRI/2025/04/084363 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of recovery of neuromuscular blockade of atracurium with neostigmine versus rocuronium with sugammadex in hepatopancreatic biliary surgeries - A Randomised Control Trial |
|
Scientific Title of Study
|
Comparison of recovery of neuromuscular blockade of atracurium with neostigmine versus rocuronium with sugammadex in hepatopancreatic biliary surgeries - A Randomised Control 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 |
Dr Lakshay Manchanda |
| Designation |
Senior resident, Department of Anaesthesia |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
E-62 second floor double storey Ramesh nagar
South West
DELHI
110015
India |
| Phone |
7011743941 |
| Fax |
|
| Email |
fdranzer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary Sciences, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary Sciences, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences, Vasant Kunj New Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary sciences vasant kunj |
| Address |
D-1 vasant kunj New Delhi 110070 |
| 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 |
| Lakshay manchanda |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
Department of anaesthesia, Institute of liver and biliary sciences vasant kunj New Delhi 110070
South West
DELHI |
7011743941
fdranzer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of liver and biliary sciences vasant kunj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing major hepatopancreatic biliary surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of atracurium and reversal with neostigmine |
To observe recovery of neuromuscular blockade of atracurium after administration of neostigmine and record time taken to achieve a train of four ratio 0.7 |
| Intervention |
Use of rocuronium and reversal with sugammadex |
To observe recovery of neuromuscular blockade of rocuronium after administration of sugammadex and record time taken to achieve a train of four ratio of 0.7 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give informed consent
Patients undergoing major hepatopancreatic biliary surgeries |
|
| ExclusionCriteria |
| Details |
Patients with refusal to participate
Patients with neuromuscular weakness
Acidosis
Electrolyte abnormalities
Myesthenia gravis |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to achieve Train of four ratio of 0.7 |
At 30 second intervals after giving reversal agent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to achieve Train of four ratio 0.9
Heamodynamics during extubation
Time taken to pass first flatus |
Till post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients Undergoing major hepatopancreatic biliary surgeries will be given either atracurium for neuromuscular blockade followed by reversal with neostigmine Or rocuronium followed by reversal with sugammadex and time taken to recovery of blockade and heamodynamics will be noted at the end of surgery |