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CTRI Number  CTRI/2020/06/025726 [Registered on: 09/06/2020] Trial Registered Prospectively
Last Modified On: 07/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate if combination of low dose rocuronium with magnesium sulphate and ketamine provides better intubating conditions at 60 seconds compared to high dose rocuronium alone, in adults. 
Scientific Title of Study   Comparative study of intubating conditions at 60 seconds between high dose rocuronium and combination of low dose rocuronium with magnesium sulphate and ketamine in adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rekha Varghese 
Designation  Professor 
Affiliation  Amrita Institute of medical sciences 
Address  Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Ernakulam
KERALA
682041
India 
Phone  9447325249  
Fax    
Email  rekhavarghese@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Rekha Varghese 
Designation  Professor 
Affiliation  Amrita Institute of medical sciences 
Address  Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Ernakulam
KERALA
682041
India 
Phone  9447325249  
Fax    
Email  rekhavarghese@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dimple Elina Thomas 
Designation  MD resident 
Affiliation  Amrita Institue of medical sciences 
Address  Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Amrita Institute of medical sciences Ponekkara Kochi Department of Anaesthesiology
Ernakulam
KERALA
682041
India 
Phone  9645506315  
Fax    
Email  dimpleelina93@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology fund Amrita Institute of medical sciences Ponekkara Kochi 
 
Primary Sponsor  
Name  Amrita Hospital 
Address  Amrita Institute of medical sciences Ponekkara Kochi 682041 
Type of Sponsor  Private 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 
Rekha Varghese  Amrita Institute of medical sciences   Department of Anaesthesiology
Ernakulam
KERALA 		 9447325249

rekhavarghese@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To evaluate if combination of low dose rocuronium with magnesium sulphate and ketamine provides better intubating conditions at 60 seconds compared to high dose rocuronium alone.  One group of patients will be receiving combination of low dose rocuronium 0.6 mg/kg IV with magnesium sulphate 30 mg/kg IV and ketamine 1 mg/kg IV which will be compared to the other group receiving high dose rocuronium 0.9 mg/kg alone. 
Comparator Agent  To evaluate if combination of low dose rocuronium with magnesium sulphate and ketamine provides better intubating conditions at 60 seconds compared to high dose rocuronium alone.  One group of patients will be receiving combination of low dose rocuronium 0.6 mg/kg IV with magnesium sulphate 30 mg/kg IV and ketamine 1 mg/kg IV which will be compared to the other group receiving high dose rocuronium 0.9 mg/kg alone. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 - 65 years
ASA PS 1-2
BMI 18.5 - 24.9 kg/m2
Mallampati grade 1-2
Elective surgery under general anaesthesia requiring intubation 
 
ExclusionCriteria 
Details  Neuromuscualr disease
Renal insufficiency
Hepatic insufficiency
Allergy to study drugs
Breast feeding or pregnancy
Anticipated difficult airway
Heart block
Recent histort of URTI 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate if combination of low dose rocuronium 0.6 mg/kg IV with magnesium sulphate 30 mg/kg IV and ketamine 1 mg/kg IV provides better intubating conditions compared to high dose rocuronium 0.9 mg/kg IV alone,at 60 seconds.  At 60 seconds after induction. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic response mean arterial pressure and heart rate between the two groups  At baseline, after induction, after intubation, 3 minutes and 6 minutes thereafter. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/06/2020 
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="30" 
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   Rocuronium is a non depolarizing muscle relaxant used for rapid sequence induction in conditions where succinylcholine is contraindicated. In this randomized control study we would be looking forward to find out if combination of low dose rocuronium 0.6 mg/kg IV with magnesium sulphate 30 mg/kg IV and ketamine 1 mg/kg IV provides better intubating conditions at 60 seconds compared to high dose rocuronium 0.9 mg/kg IV alone. We would also be looking at the hemodynamic response between both the groups. 
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