| CTRI Number |
CTRI/2025/02/080445 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare Suggamadex and Neostigmine in elderly patients undergoing general anaesthesia using Vecuronium |
|
Scientific Title of Study
|
A Randomised study to compare Suggamadex Vs Neostigmine in Reversal of Vecuronium based Neuromuscular Block in Geriatric patients. |
| 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 Kalieswaran Murugan |
| Designation |
Post graduate student |
| Affiliation |
Department of Anaesthesia, Gauhati medical college and hospital, |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical college and Hospital,Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
8072503078 |
| Fax |
|
| Email |
kamikazekalieswaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Gauhati medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical college and Hospital, Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Gauhati medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical college and Hospital, Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Bhangagarh, Guwahati-781032 |
|
|
Primary Sponsor
|
| Name |
Dr Kalieswaran Murugan |
| Address |
Post graduate student, Department of Anaesthesia and Critical care, Gauhati medical college and Hospital, Guwahati-781032 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Rajib Hazarika |
Gauhati Medical College and Hospital |
All Operation Theatres, Gauhati Medical college and Hospital,Bhangagarh, Guwahati-781032
Kamrup
ASSAM |
9864063140
rajibhazarika8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati Medical College and Hospital |
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 |
At the end of the surgery(When the TOF monitor is at 2-3 twitches), Inj.Neostigmine(along with Inj. Glycopyrolate ) is given immediately through intravenous route only once as the reversal agent for neuromuscular block .Inj. Neostigmine is given at a dose of 0.05mg per kg Body weight of patient (Total dose not to exceed 5 mg) and Inj. Glycopyrolate is given at a dose of 0.01 mg/kg Body weight of the patient (Total dose not to exceed 1mg) .Neostigmine and Glycopyrolate is diluted into 10 ml with Normal Saline (0.9 % NaCl solution). Inj. Glycopyrolate is added to minimize the muscarinic side effects of Inj. Neostigmine ,which is a Standard Practice . |
| Intervention |
SUGGAMADEX |
At the end of the surgery(when the TOF monitor is at 2-3 twitches), Inj. Suggamadex is given immediately as a Reversal agent for Neuromuscular block.It is given through intravenous route as a single dose of 2mg per kg bodyweight of the patient(only once). It is diluted into 10 ml with Normal saline(0.9% NaCl solution) . |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1)Patient with age greater than 60 years irrespective of sex of the patient.
2)Patient who are undergoing Elective Surgery in various OT under general anesthesia
3)Patients with ASA grade 1 and 2
4)Patients who have given written and informed consent |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1)Patient refusal to give consent
2)Patient with any known or suspected neuromuscular disease
3) Anticipated difficult intubation
4)History suggestive of sensitivity to drugs used in the study
5)Personal or Family history of Malignant hyperthermia
6)Patient with known case of Chronic Kidney Disease
7)Patient with known case of Chronic Liver Disease |
|
|
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 |
| recovery time from administration of reversal to reach train of four ratio greater than or equal to 0.9 |
1 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to tracheal extubation |
1.5 hrs |
| Time of shifting the patient from Operating Room to Post Operative Care Unit |
2 hrs |
Hemodynamic change
( Heart Rate , Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure , ECG rhythm ) after administration of the reversal |
baseline (2minutes before drug administration) & each minute(1 minute , 2 minutes, 3 minutes, etc )after drug administration till Train recovery time from administration of reversal to reach train of four ratio greater than or equal to 0.9 (1 hr(60 minutes)) |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
27/02/2025 |
| 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 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 is a prospective, double-blind , randomised control study to be conducted in various Operation Theatres under the Department of Anaesthesiology and Critical Care,Gauhati Medical college and hospital, Guwahati. The study will be carried out on Geriatric patients ( age greater than 60 years ) of both sexes posted for elective surgeries.The aim of this study is to compare the Neuromuscular block recovery by using Suggamadex vs Neostigmine for Vecuronium Neuromuscular block in Geriatric patients undergoing General Anaesthesia. The Secondary objective of this study is to compare the time to extubation, time of shifting the patient from Operating Room and hemodynamic changes after administration of reversal agent.
|