| CTRI Number |
CTRI/2025/07/090211 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing how fast muscle relaxation is reversed using sugammadex and neostigmine together with neostigmine alone in patients undergoing laparoscopic surgery
|
|
Scientific Title of Study
|
Comparing the speed of reversal of neuromuscular blockade by combination of Sugammadex and neostigmine with neostigmine alone in patients undergoing laparoscopic surgery |
| 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 Roshini P A |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER campus road, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708265686 |
| Fax |
|
| Email |
roshini7698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Rajeswari T |
| Designation |
Additional professor and guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER campus road, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9585887311 |
| Fax |
|
| Email |
dr.chitrarajeswari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitra Rajeswari T |
| Designation |
Additional professor and guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER campus road, Gorimedu, Dhanvantari Nagar
PONDICHERRY
605006
India |
| Phone |
9585887311 |
| Fax |
|
| Email |
dr.chitrarajeswari@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Fund, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER campus road, Gorimedu, Dhanvantari Nagar, Pondicherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER campus road, Gorimedu, Dhanvantari Nagar, Pondicherry 605006 |
| 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 |
| Dr Roshini P A |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department of Anaesthesiology and critical care,JIPMER campus road, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY |
7708265686
roshini7698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ( INTERVENTIONAL STUDIES ) JIPMER, PONDICHERRY |
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 |
Neostigmine |
Neostigmine 50 mcg/kg with glycopyrrolate 10 mcg/kg will be administered when TOF count is two or more. |
| Intervention |
Neostigmine with sugammadex |
Sugammadex 1 mg/kg followed by Neostigmine 50 mcg/kg with glycopyrrolate 10 mcg/kg will be administered when TOF count is two or more. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2, between 18-65 years scheduled to undergo laparoscopic surgery. |
|
| ExclusionCriteria |
| Details |
1.Allergy to study drugs
2.BMI more than 30
3.Serum creatinine more than 2.0 mg per dL
4.Patients taking hormonal birth control pills.
5.Breastfeeding mothers
6.Patients with anticipated difficult airway
7.Patients with suspected or known to have neuromuscular disorders.
8.H/o malignant hyperthermia
Patients receiving medication at a dose or time known to interfere with NMBAs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare the time to reach TOF ratio more than 0.9 by using (neostigmine + sugammadex) vs (neostigmine) by objective parameters such as TOFR. |
Endoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate and compare time to spontaneous breathing |
Endoperative period |
| To estimate and compare time to extubation |
Endoperative period |
| To estimate and compare incidence of RNMB in both groups using TOF and diaphragm ultrasound - Diaphragm excursion using M mode at rest and deep breathing |
Baseline, TOF more than 0.9, 30 min after shifting to PACU.
|
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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 3 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="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
|
This study is a randomized, double blinded, parallel group, single-centre trial comparing the speed of reversal of neuromuscular blockade by combination of sugammadex and neostigmine with neostigmine alone in patients undergoing laparoscopic surgery. The primary outcome is to estimate and compare the time to reach TOF ratio more than 0.9 by using ( neostigmine + sugammadex ) vs (neostigmine) by objective paramters such as TOFR. The secondary outcomes will be to estimate and compare time to spontaneous breathing, time to extubation, incidence of RNMB in both groups using TOF and diaphragm ultrasound at 3 time points- Baseline at TOF>0.9, 30 min after shifting to PACU - diaphragm excursion using M mode at rest and deep breathing. |