| CTRI Number |
CTRI/2024/10/075012 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| 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
|
Evaluation of efficacy of neostigmine vs sugammadex for reversal of vecuronium induced neuromuscular blockage in patients scheduled for elective surgeries under general anaesthesia: Prospective, double blind randomized controlled study. |
|
Scientific Title of Study
|
Evaluation of efficacy of neostigmine vs sugammadex for reversal of vecuronium induced neuromuscular blockage in patients scheduled for elective surgeries under general anaesthesia: Prospective, double blind randomized controlled 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 Swaraj Panchal |
| Designation |
1st year Resident doctor |
| Affiliation |
Sir-T Hospital Bhavnagar |
| Address |
Department of Anaesthesiology Government Medical College Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9904234064 |
| Fax |
|
| Email |
swarajpanchal174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Doshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesiology Government Medical College Bhavnagar |
| Address |
Department of Anaesthesiology Government Medical College Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428810763 |
| Fax |
|
| Email |
drshilpadoshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Doshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesiology Government Medical College Bhavnagar |
| Address |
Department of Anaesthesiology Government Medical College Bhavnagar
GUJARAT
364001
India |
| Phone |
9428810763 |
| Fax |
|
| Email |
drshilpadoshi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Sir-T Hospital Bhavnagar Gujarat 364001 |
|
|
Primary Sponsor
|
| Name |
government medical college,bhavnagar |
| Address |
government medical college,behind st bus stand,bhavnagar |
| 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 Swaraj Panchal |
Sir T hospital Bhavnagar |
Department of Anaesthesiology
Bhavnagar
GUJARAT |
9904234064
swarajpanchal174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee,GovernmentMedicalCollege,Bhavnagar |
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 |
inj. neostigmine with inj. glycopyrolate |
Patient will receive Inj. Neostigmine 0.05mg/kg with Glycopyrolate 0.008mg/kg diluted up to 10ml with normal saline
|
| Intervention |
inj. sugammadex |
giving inj. sugammadex 2mg/kg in 10ml normal saline for reversal of neuromuscular blockage. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18-60 years
ASA grade I-III.
Patient scheduled for a surgical procedure under general anaesthesia in a supine position requiring tracheal intubation.
|
|
| ExclusionCriteria |
| Details |
Difficult airway
Known neuromuscular disorders
Significant hepatic and/or renal disorders
Known family history of malignant hyperthermia
Allergies to drug
Administration of any medication interfering with NMBDs
Pregnant females or lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare recovery time from vecuronium-induced neuromuscular blockage in both the groups.
To compare the haemodynamic changes(Blood pressure, Pulse rate and SpO2) in both the groups.
|
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the side effect and complication, if any in both the groups.
|
15 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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 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
|
Evaluation of efficacy of neostigmine
vs sugammadex for reversal of vecuronium
induced neuromuscular blockage in patients scheduled for elective surgeries
under general anaesthesia: Prospective double blind randomized controlled
study.
•At
the end of the surgery, reversal of the action of neuromuscular blockage
drugs(NMBDS) is preformed to accelerate recovery from neuromuscular blockade.
At present Acetylcholinesterase inhibitors are used to reverse the action of
NMBDs which have unwanted muscarinic side effects,
such as bradycardia, hypotension, bronchoconstriction, hypersalivation and
nausea-vomiting. To overcome these muscarinic side effect, anticholinergic
drugs like glycopyrrolate is used which has its own side effects, like
tachycardia, blurred vision, sedation and possible mild confusion. [1]
•Sugammadex,
a novel drug, developed which was launched in 2021 in India, has unique
property to reverse neuromuscular blockage induced by NMBDs. It encapsulate
unbound NMBDs and reducing the free NMBD fraction at the neuromuscular junction
and that encapsulated molecule is
excreted as unchanged form in urine. [1] [2]
•Study
Design:
Prospective, double blind randomized controlled study
•Study
Setting(Site):
Operation theatre Sir-T hospital Bhavnagar.
•Study
Population: All
patients from 18 to 60 years of age will be operated under general anaesthesia
in Sir-T hospital Bhavnagar
•Study
Duration : 15
months
•Duration
of Data collection: 12
months
•Sample
Size :
Within one year after permission from EC, all the patients who will be eligible
in inclusion criteria are included in this study.
•Sampling
method :
Convenient sampling
|