| CTRI Number |
CTRI/2025/07/091077 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
participants of group 1mg per kg sugammadex combined with neostigmine 50micrograms per kg were compared with that of 2mg per kg sugammadex group for the main out come of reversal of neuromuscular block in abdominal surgries under general anaesthesia |
|
Scientific Title of Study
|
To compare safety and efficacy of 1mg/kg sugammadex combining with neostigmine 50µg/kg versus 2mg/kg sugammadex for reversal of vecuronium induced shallow neromuscular block in abdominal surgeries under general anaesthesia-A Randomised control 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 Yathish S K |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute Bangalore |
| Address |
Department of anaesthesia Bangalore medical college
Bangalore KARNATAKA 560096 India |
| Phone |
7338595885 |
| Fax |
|
| Email |
skyathish86@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yathish S K |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute Bangalore |
| Address |
Department of anaesthesia
Bangalore medical college bangalore medical college Bangalore KARNATAKA 560002 India |
| Phone |
7338595885 |
| Fax |
|
| Email |
skyathish86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yathish S K |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute Bangalore |
| Address |
Department of anaesthesia
Bangalore medical college bangalore medical college Bangalore KARNATAKA 560002 India |
| Phone |
7338595885 |
| Fax |
|
| Email |
skyathish86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical college and Research institue
bangalore 560002
karnataka
India. |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
bangalore medical college
Fort Krishna Rajendra road Kalasipalya bengalore
karnataka India 560002 |
| Type of Sponsor |
Government 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 |
| Dr Yathish S K |
Bangalore Medical College and Research institute |
department of anaesthesia BMCRI bangalore 560002 Bangalore KARNATAKA |
7338595885
skyathish86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
suggamadex 1mg per kg plus neostigmine 50microgram per kg |
to compare the time required for reversal of adequate neuromuscular blockade with suggamadex 1mg per kg with neostigmine 50 microgram/kg observed for until 1 hour after surgery is completed |
| Intervention |
suggamadex 2mg/kg |
to compare the time required for reveersal of adequate neuromuscular blockade with suggamadex 2mg/kg observed until 1 hour post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65yr
2. Patient willing to give informed consent.
3. ASA 1-2
4. Patients undergoing elective abdominal surgery under general aneasthesia
|
|
| ExclusionCriteria |
| Details |
1 Age more than 65years
2 ASA 3
3 patients undergoing emergency surgery
4 patients having allergy to drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare time required for adeqaute reversal of neuromuscular blockade .
recovery of the patient observed every 20 seconds for 1 hour post surgery |
To compare time required for adeqaute reversal of neuromuscular blockade .
recovery of the patient observed every 20 seconds until 1 hour post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to know the side effects |
observed until 1 hour post surgery |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="0" Months="3" 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
|
Elective abdominal surgeries are planned procedures, and can include procedures like appendectomy, cholecystectomy, hernia repair, and colorectal surgery, often performed laparoscopically for better recovery. Laparoscopic surgery is now widely established. Benefits include reduced postoperative pain, improved cosmetic results and patient satisfaction, and reduced hospital stays. The range of surgical techniques is increasing in complexity and now includes cholecystectomy, adrenalectomy, nephrectomy, fundoplication, hernia repair, bowel resection and gynaeco logical procedures,where general anaesthesia is preferred. Sugammadex is a new reversal agent that works differently than cholinesterase inhibitor neostigmine .It binds with high affinity to vecuronium and rocuronium in blood decreasing its plasma concentration and creating a gradient between the plasma and the neuromuscular junction, This process results in removing the non depolarizing agent from there receptors as it follows the concentration gradient towards the blood. A dose of 4mg/kg and 2 mg/kg has been established for reversal of deep and shallow neuromuscular block induced by rocuronium and vecuronium.[4]However the high cost of this drug is prohibitive and is a significant limitation for its routine use in many institutions, especially when higher doses are required.Few studies have suggested that a dose of 0.22 mcg/kg Sugammadex and 34mcg/kg neostigmine accelerates recovery from TOF ratio of 0.5 to a ratio of at least 0.9 in an average of 2 min . We hypothesize that the combination of neostigmine with half dose sugammadex (1mg/kg) would be non inferior to 2mg/kg recommended dose in reversing vecuronium induced shallow NMB.Given the high cost of Sugammadex this multimodal approach would be an effective cost reducing method ,while preserving the advantage of this novel agent . |