| CTRI Number |
CTRI/2024/11/076480 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
suggamedex versus neostigmine in reversing vecuronium induced neuromuscular blockade. |
|
Scientific Title of Study
|
"A Comparative Study of Sugammadex with Neostigmine on Efficacy and Safety in Reversing Vecuronium Induced Neuromuscular Blockade in Adult 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 Jayalakshmi Mohan |
| Designation |
Senior resident |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI , PUNE |
| Address |
5th floor ,hitech building , department of anesthesiology DR D Y Patil Medical College hospital and research institute, pimpri,
pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8547835546 |
| Fax |
|
| Email |
reshmasalim63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department Of Anaesthesiology |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI , PUNE |
| Address |
Department Of Anaesthesiology , 5th Floor, Hi-tech building ,Dr D Y
Patil Medical College Hospital And Research Centre,Sant Tukaram
Nagar , Pimpri,Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department Of Anaesthesiology |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI , PUNE |
| Address |
Department Of Anaesthesiology , 5th Floor, Hi-tech building ,Dr D Y
Patil Medical College Hospital And Research Centre,Sant Tukaram
Nagar , Pimpri,Pune
Pune
MAHARASHTRA
411018
India
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy , HI Tech 5th Floor , Dr D Y Patil Medical College Hospital And Research
Centre,Sant Tukaram Nagar ,Pimpri,Pune , maharashtra, India, Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Reshma salim |
| Address |
Department Of Anaesthesiology , 5th Floor, Hi-tech building ,Dr D Y
Patil Medical College Hospital And Research Centre,Sant Tukaram
Nagar , Pimpri,Pune |
| 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 reshma salim |
Dr D Y Patil Medical College Hospital And Research Centre |
5th Floor, Hi-tech
Building,Department Of
Anaesthesiology ,Sant
Tukaram Nagar , Pimpri
,Pune,maharashtra,411
018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8547835546
reshmasalim63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee,dr d y patil medical college pune |
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 |
patients will receive 0.05 mg/kg Neostigmine IV at reappearance of second twitch(T2) of TOF before extubation |
| Intervention |
sugammadex |
patients will receive 2 mg/kg sugammadex IV at reappearance of second twitch(T2) of TOF before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and III
Subjects born in India, have never emigrated out of India and have an Indian home address.
Patients undergoing elective surgical procedures under general anaesthesia
Hemodynamically stable patients with all routine investigations within the normal limits.
Patients who give informed written consent and are willing to be a part of the study
|
|
| ExclusionCriteria |
| Details |
Age less than 18yrs and more than 65yrs
ASA grading more than III
Patients with anatomical malformations expected to lead to difficult tracheal intubation
Known or suspected neuromuscular disorders affecting NMB
Significant renal/hepatic dysfunction, (family) history of malignant hyperthermia,
Allergy to general anaesthesia medications,contraindication to study drugs
Medication known to interfere with NMBAs (such as anticonvulsants, aminoglycosides, and magnesium-containing medications)
Patients Not Giving Consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare recovery from vecuronium-induced neuromuscular blockade with sugammadex to that with neostigmine/glycopyrrolate. (fast recover, patient responsiveness) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the side effects of a single dose of sugammadex 2 mg/kg to neostigmine 0.05mg/kg (plus glycopyrrolate) in adult patients
Event of residual paralysis
Total time spend in Operating room & PACU after extubation.
 
|
6 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/11/2024 |
| 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="6"
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
|
To study the
efficacy and safety of Sugammadex versus
Neostigmine/glycopyrrolate in reversing
vecuronium induced neuromuscular blockade in adult Indian population. To compare recovery from vecuronium-induced neuromuscular blockade
with sugammadex to that with neostigmine/glycopyrrolate. (fast recover, patient
responsiveness) also to see and evaluate the side effects of a single dose of sugammadex 2
mg/kg to neostigmine 0.05mg/kg (plus glycopyrrolate) in adult patients, Event of residual paralysis,Total time spend in Operating room and PACU after extubation. |