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CTRI Number  CTRI/2020/01/022971 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 16/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two medications Dexmedetomidine and Magnesium Sulphate for control of blood pressure and heart rate during surgery and their effects on pain relief after surgery 
Scientific Title of Study   Comparison between intravenous Dexmedetomidine and Magnesium Sulphate on intraoperative hemodynamics and postoperative pain in lumbar spine surgeries: A randomised controlled trial 
Trial Acronym  MADE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Albin Aloysius Chettanil 
Designation  Postgraduate Student 
Affiliation  St Johns Medical College 
Address  Albin Aloysius Chettanil room no. 5,6 Operation theatre complex Department of Anesthesia and Critical Care St Johns Medical College Hospital Sarjapur Road Bangalore 560034

Bangalore
KARNATAKA
560034
India 
Phone  8951190342  
Fax    
Email  albinchettanil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Manjula Devi 
Designation  Associate Professor 
Affiliation  St Johns Medical College 
Address  Dr M Manjula Devi Room no. 5,6 Operation theatre complex Department of Anesthesia and Critical Care St Johns Medical College Hospital Sarjapur Road Bangalore 560034

Bangalore
KARNATAKA
560034
India 
Phone  9449059395  
Fax    
Email  drmanjula95@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Albin Aloysius Chettanil 
Designation  Postgraduate student 
Affiliation  St. John’s Medical College 
Address  Albin Aloysius Chettanil Room no. 5,6 Operation theatre complex Department of Anesthesia and Critical Care St Johns Medical College Hospital Sarjapur Road Bangalore 560034

Bangalore
KARNATAKA
560034
India 
Phone  8951190342  
Fax    
Email  albinchettanil@gmail.com  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital Sarjapur Main Road Bangalore Karnataka 560034  
 
Primary Sponsor  
Name  St Johns Medical College And Hospital Bangalore  
Address  St Johns Medical College Sarjapur Main Road Bangalore Karnataka 560034  
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 
Dr Albin Aloysius Chettanil  St Johns Medical College Hospital  Operation Theatre Complex, room no. 4,5. 2nd floor, Anaesthesia department.
Bangalore
KARNATAKA 		 08951190342

albinchettanil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee St. John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M259||Joint disorder, unspecified, (2) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group D: Intravenous Dexmedetomidine  Bolus dose of Dexmedetomidine 1mcg/kg in 100ml Normal Saline over 15 min followed by maintenance of 0.3mcg/kg/hr until end of surgery.  
Intervention  Group M: Intravenous Magnesium   Bolus dose of Magnesium Sulpfate 30mg/kg in 100ml Normal Saline over 15 min followed by maintenance of 8mg/kg/hr until end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Adults aged 18-59 years,
undergoing elective lumbar spine surgeries
Either sex
American physical status (ASA) I and II 
 
ExclusionCriteria 
Details  Known history of hypersensitivity to drugs used
Pregnant or lactating woman
Previous spine surgeries
Preexisting neuromuscular diseases or myopathy
Coagulation disorders
Patient on Calcium channel blockers and Beta blockers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraoperative hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR)
 		 Every 5min for first half hour and then every 15min thereafter until end of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative pain by measuring numeric rating scale  Parameters are seen in recovery room (0 min, 30min, 1hr, 2hrs) and in ward at 4hrs, 6hrs, 8hrs, 10hrs, 12hrs. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   30/01/2020 
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="2"
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   This study is a randomised, double blind, parallel Group, single centre trial comparing the efficacy between intravenous Dexmedetomidine given as Bolus dose of Magnesium Sulpfate 30mg/kg in 100ml Normal Saline over 15 min followed by maintenance of 8mg/kg/hr until end of surgery and intravenous Magnesium Sulphate given as  Bolus dose of Dexmedetomidine 1mcg/kg in 100ml Normal Saline over 15 min followed by maintenance of 0.3mcg/kg/hr until end of surgery. The duration of the trial will be a period of two years. The primary outcome measured are intraoperative  hemodynamics Systolic blood pressure(SBP), Diastolic blood pressure (DBP) , Mean arterial blood pressure (MAP) and heart rate (HR). The secondary outcome is postoperative pain scores measured with numerical rating scale.

 
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