| CTRI Number |
CTRI/2024/12/077526 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the action of atracurium from vecuronium in general anesthesia |
|
Scientific Title of Study
|
A comparative study of action of atracurium vs action of vecuronium in 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 |
Dr Babneet singh kalra |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9953615240 |
| Fax |
|
| Email |
babneet890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bashir ahmad mir |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand hospital lucknow road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9682536855 |
| Fax |
|
| Email |
mirbashir96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
783657121 |
| Fax |
|
| Email |
shivamjaiswal88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun arjun medical college and rohilkhand hospital ,lucknow road banthara district shahjahanpur ,uttar pradesh(india) pin code -242307 |
|
|
Primary Sponsor
|
| Name |
Dr babneet singh kalra |
| Address |
Room no -1004 department of anesthesia first floor Varun arjun medical college and Rohilkhand hospital ,Lucknow road banthara district shahjahanpur ,uttar pradesh(india) pin code -242307 |
| 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 babneet singh kalra |
varun arjun medical college |
PAC room Department of anesthesia varun arjun medical college and Rohilkhand hospital lucknow road banthara district-Shahjahanpur ,Uttar pradesh
Shahjahanpur
UTTAR PRADESH |
9953615240
babneet890@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,varun arjun medical college & rohilkhand hospital NH-24 banthara shahjahanpur uttar pradesh |
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 |
atracurium |
Eligible participants will be randomly allocated to atracurium 0.5 mg/kg group for 1 year |
| Comparator Agent |
rocuronium |
Eligible participants will be randomly allocated to
vecuronium 0.1 mg/kg for 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status classification I or II
Patients who provide informed consent for participation. |
|
| ExclusionCriteria |
| Details |
patient over 90 kg.
Pregnant or breastfeeding women.
a history of renal, hepatic or neuromuscular disease, asthma, hypersensitivity to
anaesthetic agents.
ASA 3 or above |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the dose-response relationship
between atracurium and vecuronium during general anaesthesia |
Every 3 min for 15 min then every 15 min till
recovery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify any potential predictors of optimal
dose selection of atricurium and rocuronium based on
individual patient factors & surgical requirements |
Every 3 min for 15 min then every 15 min till
recovery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="0"
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
|
Atracurium and vecuronium are both non-depolarizing neuromuscular blocking agents used in general anesthesia to facilitate intubation and surgery. Onset and Duration of Action: Both drugs have a rapid, dose-dependent onset (1-4 minutes) and a duration of action one-third to one-half that of pancuronium. Atracurium generally has a shorter duration compared to vecuronium, making it preferable in cases requiring a brief muscle relaxation period. Metabolism: Atracurium undergoes spontaneous chemical degradation, while vecuronium is primarily metabolized by the liver. This difference in metabolism makes vecuronium more suitable for patients with normal liver function, whereas atracurium may be a better choice in cases of liver or kidney dysfunction. Clearance: Both agents have a plasma clearance rate of about 5 ml/min/kg, which is faster than many longer-acting agents, leading to rapid recovery and minimal accumulation with repeated doses. In conclusion, the choice between atracurium and vecuronium depends on factors like the desired duration of action, patient liver and kidney function, and specific surgical needs, allowing anesthesiologists to optimize patient care |