| CTRI Number |
CTRI/2025/06/089009 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two drugs: in laparoscopic surgeries with the help of clinical signs, monitoring of muscle power and ultrasonography. |
|
Scientific Title of Study
|
Comparison of Neostigmine-glycopyrrolate and sugammadex as reversal agents in laparoscopic surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavya A B |
| Designation |
DNB resident |
| Affiliation |
Ruby Hall Clinic, Pune |
| Address |
Ruby Hall Clinic, Pune
40, Sassoon Road, Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
7907513576 |
| Fax |
|
| Email |
bhavya3ab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nita Dsouza |
| Designation |
Anesthesia Consultant |
| Affiliation |
Ruby Hall Clinic Pune |
| Address |
7th floor cancer building,
Department of Anesthesia,
Ruby Hall Clinic
40 Sassoon road
Pune 411001
7th floor cancer building,
Department of Anesthesia,
Ruby Hall Clinic, Pune
40, Sassoon Road, Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavya A B |
| Designation |
DNB resident |
| Affiliation |
Ruby Hall Clinic, Pune |
| Address |
Ruby Hall Clinic,
40, Sassoon Road,
Pune-41001
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
bhavya3ab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic, Pune
40, Sassoon road,
Pune-411001 |
|
|
Primary Sponsor
|
| Name |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic, Pune
40, Sassoon road,
Pune-411001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Bhavya AB |
Ruby hall clinic, Pune |
Ruby Hall Clinic, Pune
40, Sassoon road,
Pune-411001
Pune
MAHARASHTRA |
9823721982
bhavya3ab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation |
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 |
| Comparator Agent |
Comparison of Neostigmine-glycopyrrolate group 1/N combination and group 2/S
sugammadex as reversal agents in laparoscopic surgeries |
Group and Dose
Group 1/ N: Neostigmine (2.5mg)-glyco (0.4mg) i.v.for reversal
Group 2/ S: Sugammadex 2mg/kg iv for reversal
Route: intravenous
Frequency: Give at extubation intravenously
Duration over 3-5 minutes |
| Intervention |
Reversal agent for comparison |
Group 1/ N: Neostigmine (2.5mg)-glyco (0.4mg) for reversal i.v.
Group 2/ S: Sugammadex 2mg/kg iv for reversal
The two groups compared on basis of TOF monitoring, clinical assessment and ultrasonography of respiratory muscles to assess adequacy of reversal from muscle relaxant at extubation, 15 minutes, 30 minutes and 45 minutes after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1/2 cases
2. BMI-18-26
3.No contraindication for receiving rocuronium
4.Laparoscopic surgeries lasting upto 2-3 hrs |
|
| ExclusionCriteria |
| Details |
1.Allergy to rocuronium, sugammadex or neostigmine
2.malignant hyperthermia
3.hepatic or renal insufficiency
4.neuromuscular diseases
5.inability to give consent
6.Head, neck-face surgeries, thoracic and open abdominal surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the post operative residual paralysis in both groups using TOF, clinical assessment and ultrasound
|
3 readings of TOF pre extubation
3 readings of TOF post extubation at 15, 30 and 45 minutes
Clinical assessment at same time points
respiratory muscle assessment by sonography at 30 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse events in either group
Group 1/ N: Neostigmine (2.5mg)-glyco (0.4mg) for reversal
Group 2/ S: Sugammadex 2mg/kg iv for reversal
|
around extubation-45 minutes after extubation when patient in recovery room |
|
|
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)
|
28/06/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - OPEN AVAILABILITY
- For how long will this data be available start date provided 26-04-2026 and end date provided 30-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
comparison of neostigmine-glycopyrrolate and sugammadex as reversal agents in laparoscopic surgeries. all perioperative conditions kept identical.computer generated randomization list will be followed while administering reversal agents. Investigator and participant will be blinded.Thickening fraction of internal oblique and diaphragm will be intially measured and also repeated 30 minutes after extubation. Three TOF readings are taken before extubation and 15,30 and 45 minutes after extubation.Also time to achieve TOF 0.9 after administering reversal agent is also noted.Clinical signs like headlift, tongue protrusion and cough reflex are noted during extubation and in post operative period.Adverse effects like bronchospasm, hypoxia, bradycardia, respiratory distress and PONV are also noted |