| CTRI Number |
CTRI/2024/08/071853 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to Compare the efficacy of two different doses of sugammadex for reversal of vecuronium induced neuromuscular blockage in patients posted for elective surgeries under general anesthesia |
|
Scientific Title of Study
|
Comparision of the efficacy of two different doses of sugammadex for reversal of vecuronium induced neuromuscular blockage in patients posted for elective surgeries under general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyeshkumar Gajjar |
| Designation |
Resident doctor |
| Affiliation |
GMC Bhavnagar gujarat |
| Address |
Department of Anesthesiology,1st floor,Near main operation theater,Sir T hospital bhavnagar 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9624037769 |
| Fax |
|
| Email |
dr.divyeshgajjar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Professor |
| Affiliation |
GMC Bhavnagar gujarat |
| Address |
Department of Anesthesiology,1st floor near main operation theater,Sir T hospital,
Bhavnagar, Gujarat – 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal212@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate Professor |
| Affiliation |
GMC Bhavnagar gujarat |
| Address |
Department of Anesthesiology,1st floor near main operation theater,Sir T hospital,
Bhavnagar, Gujarat – 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,Government medical college,Kalanala road,Bhavnagar,Gujarat,India 364001 |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Department of Anesthesiology,1st floor near main operation theater,Sir T hospital,
Bhavnagar, Gujarat – 364001 |
| 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 |
| DrDivyeshkumar Gajjar |
Sir Takhtasinhji Hospital, Bhavnagar |
Main operation theater,Above blood bank,Sir T. General Hospital, jail road, Kalanala Bhavnagar
Bhavnagar
GUJARAT |
9624037769
dr.divyeshgajjar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee govt medical college bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Sugammadex 1mg/kg |
Compare efficacy of reversal by Inj.Sugammadex dose 1mg/kg with 2mg/kg in vecuronium induced neuromuscular blockage after T2 appearance on TOF |
| Comparator Agent |
Inj.Sugammadex 2mg/kg |
Compare efficacy of reversal by Inj.Sugammadex dose 2mg/kg with 1mg/kg in vecuronium induced neuromuscular blockage after T2 appearance on TOF |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18 to 60 years
2 ASA grade 1 to 3
3 schedule for elective surgery under general anesthesia
4 Surgery duration less than 2 hours
5 BMI less than30 |
|
| ExclusionCriteria |
| Details |
Suspected difficult intubation
Significant hepatic and renal dysfunction
Any suspected neuromuscular disorder
Known or suspected family history of malignant hyperthermia
Lactating or pregnant female
|
|
|
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 |
To compare clinical recovery profile of two different dose of sugammadex in terms of time require for spontaneous eye opening, adequate tidal volume (5ml/kg) , hand grip for 5 seconds and time requires for extubation.
|
At baseline,Immediate after Inj.sugammadex and after 5min,10min,15min,30min,60min,90 min,120min after Inj.sugammadex |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the hemodynamic changes(Mean arterial pressure, Heart rate) after Inj. sugammadex
2. Side effects (If any) after Inj. sugammadex in both groups.
|
At baseline,Immediate after Inj.sugammadex & after 5min,10min,15min,30min,60min,90 min,120min after Inj.sugammadex |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/09/2024 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Sugammadex is novel drug launched in india for reversal of vecuronium induced neuromuscular blockage in patients undergoing general anesthesia,but there are very few studies available for it’s optimal dosing .In this study we compare the effectiveness of two minimal dosing of inj sugammadex. In this study there will be two groups ,one will receive inj,sugammadex 1mg/kg dose and other will receive 2mg/kg dose, We will compare the clinical recovery profile of this two minimal doses . Study design :A prospective,
double blind study.
Study setting :Operation theatre,
Sir Takhtasinhji Hospital, Bhavnagar.
Study duration :15 months
Duration of data collection :12 months
Sample size : Patients
undergoing elective surgical procedure requiring general
anesthesia on Tuesday and Friday during study duration period
Sampling method :Convenient sampling
Randomization :Patient
will be allocated into one of the study group by computer generated random numbers
|