| CTRI Number |
CTRI/2023/06/053643 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| 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 comparative study of intubating conditions and hemodynamic parameters during general anesthesia using rocuronium and vecuronium in patients undergoing laparoscopic surgeries. A prospective randomized double blind study |
|
Scientific Title of Study
|
"A Comparative study of intubating conditions and haemodynamic parameters during general anaesthesia using Rocuronium and Vecuronium in patients undergoing laparoscopic surgeries.†A prospective randomized double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GUBBI VISHWANATH SAI ASHRAY |
| Designation |
POSTGRADUATE STUDENT. |
| Affiliation |
POSTGRADUATE STUDENT. |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
Dharwad
KARNATAKA
570009
India |
| Phone |
|
| Fax |
|
| Email |
ashraysai.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHAMMAD ASIF KALAS |
| Designation |
ASSOCIATE PROFESSOR. |
| Affiliation |
ASSOCIATE PROFESSOR. |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
Dharwad
KARNATAKA
570009
India |
| Phone |
|
| Fax |
|
| Email |
asifkalas189@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GUBBI VISHWANATH SAI ASHRAY |
| Designation |
POSTGRADUATE STUDENT. |
| Affiliation |
POSTGRADUATE STUDENT. |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR, DHARWAD DISTRICT, KARNATAKA.
Dharwad
KARNATAKA
570009
India |
| Phone |
|
| Fax |
|
| Email |
ashraysai.98@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES
AND HOSPITAL, SATTUR, DHARWAD DISTRICT- 50009 |
| 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 GUBBI VISHWANATH SAI ASHRAY |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, SATTUR , DHARWAD DISTRICT, KARNATAKA
Dharwad
KARNATAKA |
8147161773
ashraysai.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- SDM COLLEGE OF MEDICAL SCIENCE |
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 |
| Intervention |
Injection Rocuronium |
The study Muscle Relaxant Injection Rocuronium 0.6mg/kg intravenous route intubating dose. Maintenance dose 0.1mg/kg every 40 minutes once until surgery is done.
The intubating conditions and hemodynamic parameters will be studied as per the proforma. |
| Comparator Agent |
Injection Vecuronium |
The study Muscle Relaxant Injection vecuronium 0.1mg/kg intravenous route intubating dose. Maintenance dose Injection vecuronium 0.03mg/kg intravenous route every 40 minutes once, until surgery is done. The intubating conditions and hemodynamic parameters will be studied as per the proforma. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-1 & 2
|
|
| ExclusionCriteria |
| Details |
ANTICIPATED DIFFICULT AIRWAY.
ASA 3 AND ABOVE.
ANTICIPATED MAJOR BLOOD LOSS.
MAJOR SYSTEMIC DISEASES. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| inj. Rocuronium 0.6mg/kg provides better intubating conditions and maintains stable hemodynamic parameters during general anesthesia. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the adverse drug reaction caused by either of the the muscle relaxant used and also the time interval required between the intubating dose and 1st top up. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/06/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashraysai.98@gmail.com].
- For how long will this data be available start date provided 23-11-2027 and end date provided 23-11-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
THIS IS A RANDOMISED DOUBLE BLINDED STUDY WHERE WE ARE COMPARING THE HEMODYNAMIC PARAMETERS AND INTUBATING CONDITIONS USING ROCURONIUM AND VECURONIUM DURING GENERAL ANAESTHESIA IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES. HERE WE WILL BE USING EQUIPOTENT DOSES OF BOTH THE MUSCLE RELAXANT, THAT IS THE 2 TIMES ED 95 OF BOTH THE DRUGS. AS PER THE EXPECTED OUTCOME ROCURONIUM WILL PROVIDE MORE STABLE HEMODYNAMIC CONDITIONS AND BETTER INTUBATING CONDITIONS WHEN COMPARED TO VECURONIUM. |