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CTRI Number  CTRI/2018/04/013000 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On: 24/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexmedetomidine causes change in vital parameters after intubation 
Scientific Title of Study   “Attenuation of pressor response to laryngoscopy and tracheal intubation in adult patients with intravenous Dexmedetomidine.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gajanan Sanjay More 
Designation  Junior resident 
Affiliation  ESIPGIMSR and Model hospital Andheri east Mumbai 
Address  Department of anesthesiology ESIPGIMSR and model Hospital Andheri east central road Mumbai infront of MIDC police station Mumbai 400093

Mumbai
MAHARASHTRA
400093
India 
Phone  8975977409  
Fax    
Email  gajuraje81@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandhya Gujar 
Designation  Professor and HOD 
Affiliation  ESIPGIMSR and Model hospital Andheri east Mumbai 
Address  Professor and Head Department of anesthesiology ESIPGIMSR and model Hospital Andheri east central road Mumbai infront of MIDC police station Mumbai 400093

Mumbai
MAHARASHTRA
400093
India 
Phone  9869074329  
Fax    
Email  drsandhyagujar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandhya Gujar 
Designation  Professor and HOD 
Affiliation  ESIPGIMSR and Model hospital Andheri east Mumbai 
Address  Professor and Head Department of anesthesiology ESIPGIMSR and model Hospital Andheri east central road Mumbai infront of MIDC police station Mumbai 400093

Mumbai
MAHARASHTRA
400093
India 
Phone  9869074329  
Fax    
Email  drsandhyagujar@gmail.com  
 
Source of Monetary or Material Support  
ESIPGIMSR and Model hospital Andheri east Mumbai 
 
Primary Sponsor  
Name  ESIPGIMSR and Model hospital andheri 
Address  ESIPGIMSR and model Hospital Andheri east central road Mumbai infront of MIDC police station Mumbai 400093  
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 Gajanan Sanjay More  ESIPGIMSR and Model Hospital Andheri Mumbai  ESIPGIMSR and model Hospital Andheri east central road Mumbai infront of MIDC police station Mumbai 400093
Mumbai
MAHARASHTRA 		 8975977409

gajuraje81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA Grade I & II patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Dexmedetomidine  1mcg/kg dexmedetomidine in 100 ml Normal Saline over 10 minute given before induction of anesthesia 
Comparator Agent  Normal Saline  100 ml Normal Saline over 10 minute given before induction of anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient posted for surgery under general anesthesia.
Patients belonging to ASA class I & II. 
 
ExclusionCriteria 
Details  1 Patients with hypertension, cardiac, respiratory, renal, hepatic &
cerebral diseases
2. Patients with difficult airway and obese patients.
3. Patients with endocrinal diseases like hyperthyroidism, hypothyroidism
and diabetes mellitus.
4. Pregnant patient 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To study the efficacy of 1μg/kg dexmedetomidine intravenous given in 100
ml NS over 10 minutes before induction to obtund the pressor response of
laryngoscopy and tracheal intubation with respect to- Heart rate, systolic blood
pressure, diastolic blood pressure, Mean arterial pressure. 		 Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To study any adverse effects associated, such as perioperative
hypotension, bradycardia. 		 Baseline, at 5 and 10 mins during drug infusion, after induction, at and 5,10 mins after intubation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/12/2015 
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)  Closed to Recruitment of Participants 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
"Attenuation of pressor response to
laryngoscopy and tracheal intubation in adult patients with intravenous
Dexmedetomidine” was carried out at tertiary center . 100 patients scheduled for
various elective surgical procedures belonging to ASA class I and II, in the age group
of 18 to 60 years were included in the study. The patients with hypertension, difficult
airway, obesity and any other systemic disorders were excluded from the study. The
study population was divided randomly into two groups of 50 each.
Group 1 (Dexmedetomidine) patients received IV Dexmedetomidine 1 microgram /kg
in 100ml normal saline infused over 10 min before induction
Group 2 (Saline) patients received 100 ml normal saline infused over 10 min before
induction.
All patients were Premedicated with Inj. Glycopyrrolate 0.004mg/kg, Inj.
Ondansetron 0.08mg/kg, Inj. Ranitidine 50 mg was given intravenously. Inj.
Pentazocine 0.5mg/kg and Inj. Midazolam 0.03 mg/kg were administered IV slowly.
Anaesthesia was induced with a 1% (w/v) solution of propofol 2mg/kg injected at a
rate of approximately 10mg/sec, the endpoint being the loss of the eyelash reflex.
after successful trial ventilation scholine 1.5 mg/kg was given to facilitate
laryngoscopy and intubation.
After Laryngoscopy and intubation the HR, SBP, DBP and MAP were recorded at 0
min, 5 and 10 min after intubation.
 
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