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CTRI Number  CTRI/2023/05/052811 [Registered on: 17/05/2023] Trial Registered Prospectively
Last Modified On: 17/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [Neuromuscular monitoring device ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of intubating conditions of two drugs using train of four neuromuscular monitoring by stimulating ulnar nerve with submaximal current 10-15mA 
Scientific Title of Study   Randomized Prospective Study to Compare Intubating conditions with Cisatracurium or Rocuronium using train of Four Neuromuscular Monitoring in Adult Patients Undergoing Elective Surgery  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vipin Kumar Dhama  
Designation  Professor  
Affiliation  LLRM Medical college Meerut  
Address  Department of Anaesthesiology LLRM Medical College meerut

Meerut
UTTAR PRADESH
250004
India 
Phone  9760014177  
Fax    
Email  drvipindhama@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipin Kumar Dhama  
Designation  Professor  
Affiliation  LLRM Medical college Meerut  
Address  Department of Anaesthesiology LLRM Medical College meerut

Meerut
UTTAR PRADESH
250004
India 
Phone  9760014177  
Fax    
Email  drvipindhama@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhika kukreja  
Designation  Junior resident  
Affiliation  LLRM Medical college Meerut  
Address  Department of Anaesthesiology LLRM Medical College meerut

Meerut
UTTAR PRADESH
250004
India 
Phone  7696861470  
Fax    
Email  drkukrejafk@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology LLRM Medical College meerut  
 
Primary Sponsor  
Name  Dr vipin kumar dhama  
Address  Department of anaesthesiology LLRM MEDICAL COLLEGE MEERUT  
Type of Sponsor  Government medical college 
 
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 Vipin Kumar Dhama   LLRM medical College   Department of anesthesiology surgery operation theatre block 1st floor
Meerut
UTTAR PRADESH 		 9760014177

drvipindhama@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee LLRM Medical College meerut   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 
Intervention  CISATRACURIUM   Comparison of intubating conditions with train of four neuromuscular monitoring with LOADING DOSE-0.15mg/kg MAINTAINENCE DOSE-0.03mg/kg 
Comparator Agent  ROCURONIUM   LOADING DOSE -0.6mg/kg MAINTAINENCE DOSE -0.2mg/kg  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade I and grade II Patients
Patients undergoing elective surgery  
 
ExclusionCriteria 
Details  Patient refusal
Pregnancy
Coagulopathy
Anticipated Difficult airway
Any severe systemic disease  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate intubating conditions using train of four neuromuscular monitoring with cisatracurium or rocuronium   40min 
 
Secondary Outcome  
Outcome  TimePoints 
To compare systemic effect of cisatracurium or rocuronium on hemodynamic parameters   30min 
 
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 3 
Date of First Enrollment (India)   01/06/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkukrejafk@gmail.com ].

  6. For how long will this data be available start date provided 12-04-2024 and end date provided 16-09-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Research clinical trial entitled "Randomized Prospective Study to Compare Intubating conditions with Cisatracurium or Rocuronium using train of Four Neuromuscular Monitoring in Adult Patient Undergoing Elective Surgery " will enlist 80 patients admitted to SVBP Hospital associated to LLRM Medical College meerut Undergoing various elective surgeries after informed patient consent. The enlisted patients will be divided into two groups of 40 each and primary with secondary objectives will  be observed and documented. 
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