CTRI

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CTRI Number

CTRI/2018/11/016361 [Registered on: 15/11/2018] Trial Registered Prospectively

Last Modified On:

01/08/2020

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

A clinical study to know the differences in the maximum response produced by the two drugs of two drugs (Atracurium and Cisatracurium) in terms of haemodynamic effects and pharmacological actions in the patients who are undergoing surgeries under General Anesthesia.

Scientific Title of Study

Comparison of efficacy of Atracurium versus Cisatracurium in patients undergoing surgeries under General Anaesthesia

Trial Acronym

ACA

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DrAswani Baskaran
Designation	MBBS MD ANESTHESIA 2nd yr pg
Affiliation	Chettinad Hospital and Research Institute
Address	Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Kancheepuram TAMIL NADU 603103 India
Phone	9677241756
Fax
Email	swanbkn@gmail.com

Details of Contact Person
Scientific Query

Name	DrBalamurugan B
Designation	MBBS MD
Affiliation	Chettinad Hospital and Research Institute
Address	Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Kancheepuram TAMIL NADU 603103 India
Phone	9940300100
Fax
Email	drbala.srmc@gmail.com

Details of Contact Person
Public Query

Name	DrAswani Baskaran
Designation	MBBS MD ANESTHESIA 2nd yr pg
Affiliation	Chettinad Hospital and Research Institute
Address	Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103 Kancheepuram TAMIL NADU 603103 India
Phone	9677241756
Fax
Email	swanbkn@gmail.com

Source of Monetary or Material Support

Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,TAMILNADU 603103

Primary Sponsor

Name	DrAswani Baskaran
Address	Chettinad Hospital and Research Institute , Rajiv Gandhi salai , OMR , Kanchipuram district ,chennai 603103
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Aswani Baskaran	Chettinad Hospital and Research Institute	Department of Anesthesiology and Critical Care , OT COMPLEX ( A BLOCK , D BLOCK ) Chettinad Health city Kancheepuram TAMIL NADU	9677241756 swanbkn@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	ATRACURIUM	ATRACURIUM : INTUBATION DOSE :0.5mg/kg iv MAINTENANCE DOSE :0.1mg/kg iv
Comparator Agent	CISATRACURIUM	CISATRACURIUM: INTUBATION DOSE: 0.1mg/kg iv MAINTENANCE DOSE: 0.02mg/kg iv

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	ASA I ASA II ASAIII Both elective and emergency procedures

ExclusionCriteria

Details

ASAIV
Pregnant patients
Patients with Bronchial asthma
Patients with history of cardiovascular disorders
Patients with history of hepatic and renal disorders
Patients on medications known to interact with neuromuscular blocking drugs

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Onset and duration of action of neuromuscular blocking drug	Onset of action : time from the administration of drug till TOF0. Duration of action is time from administration of drug till TOF1

Secondary Outcome

Outcome	TimePoints
Haemodynamic variability ( HR SBP DBP SPO2 ) Histamine release laryngoscopy	10min 20min 30min 45min 60min 75min 90min 105min 120min

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 2

Date of First Enrollment (India)

26/11/2018

Date of Study Completion (India)

31/07/2019

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

NOT PUBLISHED

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This study is a randomized double blinded parallel group trial comparing the efficacy of atracurium and cisatracurium in patients undergoing surgeries under general anesthesia. The loading dose (2*ED95) of ATRACURIUM is 0.5mg/kg iv and maintenance dose of ATRACURIUM is 0.1mg/kg iv.The loading dose92*ED95) of Cistracurium is 0.1mg/kg iv and maintenance dose of CISATRACURIUM is 0.02mg/kg iv. The study is conducted for a period of one year in Chettinad Hospital and research Institute. The primary outcome of the study is onset and duration of action of the neuromuscular blocking drug. The secondary outcomes are the hemodynamic variability, histamine release and condition on intubation.