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CTRI Number  CTRI/2013/11/004173 [Registered on: 27/11/2013] Trial Registered Retrospectively
Last Modified On: 27/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate the safety and efficacy of Cisatracurium Besylate Injection versus Atracurium Besylate for neuromuscular blockade in adult patients undergoing diagnostic or therapeutic surgical procedures. 
Scientific Title of Study   Prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate safety and efficacy of Cisatracuruim Besylate versus Atracurium Besylate for neuromuscular blockade in adult patients, undergoing diagnostic or therapeutic surgical procedures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Cisa/TML/06/2012;Version Number-00; date 01/06/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Shubha N Mohite  
Designation  Prof & HOD Anaesthesiology;  
Affiliation  Dr. D.Y.Patil Medical College & Hospital,  
Address  Head Department of Anesthesiology, Dr. D. Y. Patil Medical College & Hospital, Nerul, Navi Mumbai

Mumbai
MAHARASHTRA
400 076;
India 
Phone  9820409985  
Fax    
Email  shubha.mohite@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Shubha N Mohite  
Designation  Prof & HOD Anaesthesiology;  
Affiliation  Dr. D.Y.Patil Medical College & Hospital,  
Address  Head Department of Anaesthesiology, Dr. D. Y. Patil Medical College & Hospital, Nerul, Navi Mumbai

Mumbai
MAHARASHTRA
400 076
India 
Phone  9820409985  
Fax    
Email  shubha.mohite@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumedh M Gaikwad 
Designation  Director-Medical Services 
Affiliation  Themis Medicare Limited 
Address  11/12, Udyog Nagar, S. V. Road, Goregaon, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400 104
India 
Phone  67603333  
Fax  67607070  
Email  sumedh.gaikwad@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare Limited 
 
Primary Sponsor  
Name  Themis Medicare Limited 
Address  11/12, Udyog Nagar, S. V. Road, Goregaon (West), Mumbai 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Jaishri Bogra  C.S.M.M./KGMU University  Department of Anaesthesiology, Lucknow - 226 003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 09839075895

lkojbogra@yahoo.in 
Dr Malathi Panchawagh  Deenanath Mangeshkar Hospital & Research Centre  Department of Anaesthesia, First floor, Pune - 411 004
Pune
MAHARASHTRA 		 09822437176

sujaylakshmi@gmail.com 
Prof Dr Shubha Nandkumar Mohite  Dr. D. Y. Patil Medical College & Hospital  Head Department of Anaesthesiology, Nerul, Navi Mumbai - 400 076
Mumbai
MAHARASHTRA 		 09820409985

shubha.mohite@gmail.com 
Dr Abhijit Paul  Medica Superspecialty Hospital  HOD of Anaesthesia and Pain Services, 127, Mukundapur, E.M.Bypass, Kolkata - 700 099
Kolkata
WEST BENGAL 		 09831074339

abhijit.paul@medicasynergie.in 
Dr S B Gangadhar  Sri Siddhartha Medical College and Research Institute  Professor and Head Department of Anaesthesiology, Agalakote, B. H. Road, Tumkur - 572 107
Tumkur
KARNATAKA 		 09341239804

clinicombiosolution@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Clinical Research Ethics Committee.... Medica Superspecialty Hospital, Kolkata... Dr. Abhijit Paul  Approved 
Institutional Ethics Committee......CSMM/King Georges Medical University...... Dr. Jaishri Bogra  Approved 
Institutional Ethics Committee....Deenanath Mangeshkar Hospital and Research Centre........ Dr. Malathi Panchawagh  Approved 
Institutional Ethics Committee....Dr. D.Y. Patil Medical College and Hospital and Research Centre..... Dr. Shubha N. Mohite  Approved 
Institutional Review Board, Sri Siddhartha Medical College & Research Centre.........Dr. S. B. Gangadhar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neuromuscular Blockade in adult patients undergoing diagnostic or therapeutic surgical procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Atracurium Besylate Injection  Initial dose of 0.4 to 0.5 mg/kg is administered IV. The first maintenance dose will generally be required 20 to 45 minutes after the initial atracurium besylate injection, Atracurium besylate doses of 0.08 to 0.10 mg/kg are recommended for maintenance of neuromuscular block maintenance doses may be administered at relatively regular intervals for each patient, ranging approximately from 15 to 25 minutes under balanced anesthesia 
Intervention  Cisatracurium Besylate Injection  Initial dose will be 0.15 to 0.2 mg/kg prior to intubation Maintenance doses of 0.03 mg/kg each will sustain neuromuscular block for approximately 20 minutes. Maintenance dosing is generally required 40 to 50 minutes following an initial dose of 0.15 mg/kg cisatracurium and 50 to 60 minutes following an initial dose of 0.20 mg/kg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1. Patients of either sex in the age group between 18 to 65 years.
2. Patients scheduled for elective diagnostic / therapeutic surgical procedure to be completed within 120 minutes with an ASA status ranging from P1 to P4
3. Subjects who provide a written informed consent to abide by the study requirements.
 
 
ExclusionCriteria 
Details  1. Patients undergoing emergency surgical procedure / surgical procedure with likely duration for completion 120 minutes.

2. Patients receiving medication known to interfere with neuromuscular blockers for e.g. : anti-convulsants, amino glycosides or polypeptide antibiotics, magnesium

3. Patients with anticipated difficult intubation (Mallampati score III and more)
4. Patients with diseases affecting neuromuscular transmission (myasthenia gravis or myopathies).
5. Subjects known or suspected to have a (family) history of malignant hyperthermia
6. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
7. Patients treated with any other oral / parenteral opioids or benzodiazepines within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period.
8. Patients suffering from organic neurological disorders, psychiatric illnesses and H/o drug abuse.
9. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
10.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
11. Pregnant and lactating females.
12. Patients simultaneously participating in another clinical study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy parameters   The train of four will be recorded every 10 min for the first 2 h (period of surgery) and then at least hourly until complete spontaneous recovery (maximum period of 6 hours) as evident from recording of train-of-four without fade phenomenon. 
 
Secondary Outcome  
Outcome  TimePoints 
Safety parameters-  The BP, pO2, respiratory rate, pulse (HR), QTc interval(ECG), will be recorded prior to anaesthesia, during anesthesia and surgery at 10 minutes interval till end of surgery, while in the post operative period will be recorded at 2 hrs, 4hrs and 6 hours.
Haematological and serological investigations will be done before the procedure and at the end of 6 hours after surgery.
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   19/11/2013 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Prospective, observer blind, randomized, parallel group, comparative, 2- arm study to   evaluate safety and efficacy of cisatracurium besylate versus atracurium besylate for neuromuscular blockade in adult patients undergoing diagnostic or therapeutic surgical procedures. 
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