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CTRI Number  CTRI/2018/05/014201 [Registered on: 29/05/2018] Trial Registered Prospectively
Last Modified On: 24/05/2018
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 clinical trial to study the effect of two drugs, rocuronium and cisatracurium in adults subjected to general anaesthesia. 
Scientific Title of Study   A Comparative Study Of Intubating Doses Of Rocuronium And Cisatracurium In Adults Undergoing Elective Surgeries Under General Anaesthesia-A Double Blind Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Paramanand Reddy 
Designation  Junior Resident-1st Year 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology, FMMC, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7411417045  
Fax    
Email  drpreddy92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshavardhan K 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology, FMMC, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9980124362  
Fax    
Email  harshaomega@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Paramanand Reddy 
Designation  Junior Resident-1st Year 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology, FMMC, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7411417045  
Fax    
Email  drpreddy92@gmail.com  
 
Source of Monetary or Material Support  
Dr Paramanand Reddy, JR-1st year, Dept of Anaesthesiolgy, FMMC, Kankanady, Mangalore-575002. Karnataka. 
 
Primary Sponsor  
Name  Dr Paramanand Reddy 
Address  FMMC, Kankanady, Mangalore 575002. Karnataka, India. 
Type of Sponsor  Other [Principal Investigator] 
 
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 Paramanand Reddy  Father Muller Medical College  Dept. of Anaesthesiology, FMMC, Kankanady, Mangalore-575002.
Dakshina Kannada
KARNATAKA 		 7411417045

drpreddy92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All adults undergoing elective surgeries under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal intubation with cisatracurium  To assess and compare the feasibility of intubation using rocuronium and cisatracurium 
Intervention  Endotracheal intubation with rocuronium  To assess and compare the feasibility of intubation using rocuronium and cisatracurium.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients posted for elective surgeries under general anaesthesia
2) ASA 1 and 2
3) Mallampatti grade 1 and 2
4) Surgery with duration more than 30 minute 
 
ExclusionCriteria 
Details  1) Restricted arm positions or likely changes in arm position during surgery
2) Patients who require rapid sequence intubation
3) Patients undergoing laparoscopic surgeries
4) Patients on aminoglycoside therapy or those who may need it intraoperatively 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
a)Hemodynamic variables(Heart rate; systolic, diastolic and mean arterial pressure) will be recorded at successive intervals like T0, T1, T2, T3, T4, T5, T6, T7, T8 and Tn.
b) Intubating conditions assessed and graded based on ease of passage of tube with or without coughing/bucking and vocal cord position. 		 T0-Before induction.
T1-After induction.
T2-After injection of neuromuscular blocker.
T3-Just after intubation.
T4, T5, T6, T7, T8-At a successive interval of 2min each after T3.
Tn-At a successive interval of 10min each after T8. 
 
Secondary Outcome  
Outcome  TimePoints 
a) onset time of neuromuscular blockade
b) clinical duration of neuromuscular blockade
c) recovery index
d) any adverse reaction to the drug 		 a) Time from injection of neuromuscular blocker to 95% supression of twitch height
b) Time from injection of neuromuscular blocker to 25% recovery of twitch height
c)Time from 25% to 75% recovery of twitch height 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/06/2018 
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 Applicable 
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)?  

Brief Summary   The first successful administration of a neuromuscular blocker (curare) to produce surgical relaxation in an anaesthetized patient occurred in 1912, when Arthur Lawen,  a German surgeon from Leipzig, used a partially purified preparation of the substance. Since their introduction, muscle relaxants have become a part and parcel of every anaesthesiologist’s routine practice.

 These agents aid not only in endotracheal intubations and mechanical ventilation but also decrease anaesthetic requirement, patient movement and oxygen consumption. Newer and novel addition to this drug arsenal are cisatracurium and rocuronium. 

Cisatracurium is a new intermediate duration, non-depolarizing, benzylisoquinolinium neuromuscular blocking drug which is a stereoisomer of atracurium. It exhibits stable cardiovascular profile and organ dependent Hoffman elimination. Cisatracurium does not trigger histamine release and the adult ED95 is 0.05mg/kg.

Rocuronium which is also an intermediate duration drug, is an aminosteroidal non depolarizing neuromuscular blocker and analogue of vecuronium. As with cisatracurium, even rocuronium doesn’t trigger histamine release and the adult ED95 is 0.3mg/kg.

Given the fact that both drugs exhibit a good safety profile, we are interested to know whether the standard induction doses could be exceeded to provide more favourable conditions for intubation. Also, studying the onset and duration of action of a single intubating dose is on the agenda. As there are not many Indian studies comparing cisatracurium and rocuronium, the present study will serve as a pedestal for any such new studies in India. Our study also aims at comparing the neuromuscular blocking and hemodynamic effects of the above drugs, thus helping in choosing the desirable drug when in a dilemma. 

 
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