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CTRI Number  CTRI/2020/06/026088 [Registered on: 24/06/2020] Trial Registered Retrospectively
Last Modified On: 19/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of preoperative infusion of dexmedetomidine on intraoperative anaesthetic drug consumption under general anaesthesia 
Scientific Title of Study   Effect of preanaesthetic single infusion of dexmedetomidine on isoflurane consumption in surgical patients under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RESHMA B M 
Designation  JUNIOR RESIDENT 
Affiliation  M.S.RAMAIAH MEDICAL COLLEGE 
Address  M.S.RAMAIAH MEDICAL COLLEGE,DEPARTMENT OF ANAESTHESIA,M.S.RAMAIAH MEDICAL COLLEGE,MSR NAGAR,MSRIT POST,MATHIKERE,BANGALORE, KARNATAKA-560054

Bangalore
KARNATAKA
560054
India 
Phone  8892019120  
Fax    
Email  lucky3276@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  GEETHA C R 
Designation  ASSOCIATE PROFESSOR 
Affiliation  M.S.RAMAIAH MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIA,M.S.RAMAIAH MEDICAL COLLEGE,MSR NAGAR,MSRIT POST,MATHIKERE,BANGALORE, KARNATAKA-560054

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  RESHMA B M 
Designation  JUNIOR RESIDENT 
Affiliation  M.S.RAMAIAH MEDICAL COLLEGE 
Address  NO.006,GOLDEN BELL APARTMENT,4TH CROSS,SHARADAMBANAGAR,NEAR ST.CLARET SCHOOL,JALAHALLI VILLAGE,BANGALORE-560013
DEPARTMENT OF ANAESTHESIA,M.S.RAMAIAH MEDICAL COLLEGE,MSR NAGAR,MSRIT POST,MATHIKERE,BANGALORE, KARNATAKA-560054
Bangalore
KARNATAKA
560013
India 
Phone  8892019120  
Fax    
Email  lucky3276@gmail.com  
 
Source of Monetary or Material Support  
Hospital funded 
 
Primary Sponsor  
Name  M S RAMAIAH MEDICAL COLLEGE 
Address  MSR NAGAR,MSRIT POST,MATHIKERE,,BANGALORE-560054 
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 
RESHMA B M  M S RAMAIAH MEDICAL HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY,OT COMPLEX,2ND FLOOR,MSRIT POST,NEW BEL ROAD,MSR NAGAR,BENGALURU-560054
Bangalore
KARNATAKA 		 8892019120

lucky3276@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient with American Society of Anaesthesiologists Physical status 1 and 2 posted for elective surgery under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DEXMEDETOMIDINE VS NORMAL SALINE  DEXMEDETOMIDINE-1microgram/kg over 10 minutes, 15 minutes before induction. NORMAL SALINE - 25ml infusion over 10 minutes, 15 minutes before induction. 
Intervention  Intravenous infusion  single infusion of dexmedetomidine -1microgram/kg or normal saline- 25ml, 15 minutes before induction 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Age between 20 and 60 years.
- American Society of Anaesthesiologists Grade 1 and 2.
- Patients undergoing surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  - Patients allergic to study drug.
- Patients undergoing laparoscopic surgeries.
- Body Mass Index > 35 kg/m2.
- Patients on beta blockers,sedatives or stimulant drugs.
-Patients with history of psychiatric illness,alcohol abusers,altered mentation or epilepsy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of preanaesthetic administration of dexmedetomidine on isoflurane consumption.  At the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess effect of dexmedetomidine on intraoperative haemodynamic stability and recovery profile.  Baseline,every 5 minutes after infusion of study drug/placebo till end of anaesthesia heart rate,blood pressure,oxygen saturation,bispectral index values were noted. Postoperative recovery profiles were assessed using modified aldrete score at immediate postop,30 and 60 minutes. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/10/2013 
Date of Study Completion (India) 28/09/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   General anaesthesia with inhalational agents associated with adjuvant intravenous agents provide better sedation, hypnosis and analgesia. Drugs with such effects already established in literature include benzodiazepines and opioids. New intravenous agents like alpha2 adrenergic agonist produce sedation ,anxiolysis and analgesia and has good haemodynamic profile. 
Hence, it is hypothesized that preinduction loading dose of dexmedetomidine  1 microgram/kg would reduce inhalational anaesthesia agent isoflurane consumption and thus cost effective and also provide better haemodynamic stability and recovery profile.
 
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