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CTRI Number  CTRI/2018/05/014228 [Registered on: 30/05/2018] Trial Registered Retrospectively
Last Modified On: 04/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “USE OF DEXMEDETOMIDINE TO AVOID CHANGES IN PULSE AND BLOOD PRESSURE DUE TO REMOVAL OF ENDOTRACHEAL TUBE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA– PROSPECTIVE, RANDOMIZED STUDY.”  
Scientific Title of Study   “DEXMEDETOMIDINE FOR THE PREVENTION OF HAEMODYNAMIC RESPONSE TO EXTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA– PROSPECTIVE, RANDOMIZED STUDY.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SANJEEV ANEJA 
Designation  SENIOR CONSULTANT, DEPARTMENT OF ANAESTHESIOLOGY, INDRAPRASTHA APOLLO HOSPITAL NEW DELHI  
Affiliation  INDRAPRASTHA APOLLO HOSPITAL DELHI  
Address  INDRAPRASTHA APOLLO HOSPITAL, MATHURA ROAD, SARITA VIHAR, NEW DELHI.

South
DELHI
110076
India 
Phone  9810511510  
Fax    
Email  sanjeevaneja@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SANJEEV ANEJA 
Designation  SENIOR CONSULTANT, DEPARTMENT OF ANAESTHESIOLOGY, INDRAPRASTHA APOLLO HOSPITAL NEW DELHI  
Affiliation  INDRAPRASTHA APOLLO HOSPITAL DELHI 
Address  INDRAPRASTHA APOLLO HOSPITAL, MATHURA ROAD, SARITA VIHAR, NEW DELHI.

South
DELHI
110076
India 
Phone  9810511510  
Fax    
Email  Rvj4me@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SANJEEV ANEJA 
Designation  SENIOR CONSULTANT, DEPARTMENT OF ANAESTHESIOLOGY, INDRAPRASTHA APOLLO HOSPITAL NEW DELHI  
Affiliation  INDRAPRASTHA APOLLO HOSPITAL DELHI  
Address  INDRAPRASTHA APOLLO HOSPITAL, MATHURA ROAD, SARITA VIHAR, NEW DELHI.

Dhule
DELHI
110076
India 
Phone  9810511510  
Fax    
Email  sanjeevaneja@hotmail.com  
 
Source of Monetary or Material Support  
INDRAPRASTHA APOLLO HOSPITAL NEW DELHI.  
 
Primary Sponsor  
Name  INDRAPRASTHA APOLLO HOSPITAL NEW DELHI  
Address  MATHURA ROAD SARITA VIHAR NEWDELHI 110076 
Type of Sponsor  Research institution and hospital 
 
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 SANJEEV ANEJA   INDRAPRASTHA APOLLO HOSPITAL NEW DELHI   MATHURA ROAD, SARITA VIHAR NEW DELHI
South
DELHI 		 9810511510

sanjeevaneja@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE- CLINICAL STUDIES, INDRAPRASTHA APOLLO HOSPITALS NEW DELHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  ASA GRADE I & II, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.IV IV DEXMEDETOMIDINE 0.25 MCG/KG OVER 10 MINUTES PRIOR TO EXTUBATION 2.IV DEXMEDETOMIDINE 0.5 MCG/KG OVER 10 MINUTES PRIOR TO EXTUBATION 3.IV NORMAL SALINE 20CC OVER 10 MINUTES PRIOR TO EXTUBATION   INTRAVENOUS DEXMEDETOMIDINE MAY BE USEFUL FOR ATTENUATION OF EXTUBATION RESPONSE WITH TWO DIFFERENT DOSES THAT IS, 0.25 MCG/KG AND 0.5 MCG/KG & PLACEBO WITH NORMAL SALINE 
Comparator Agent  IV DEXMEDETOMIDINE 0.25 MCG/KG, IV DEXMEDETOMIDINE 0.5 MCG/KG, IV SALINE   NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 18 – 65yrs
2. Either sex.
3. Elective cases undergoing abdominal surgeries lasting more than one hour.
4. ASA I & ASA II. 
 
ExclusionCriteria 
Details  1. Patient’s refusal to take part in our study.
2. Patient on beta blockers or alpha blockers.
3. Patient requiring epidurals for post-operative pain relief.
4. Pregnant women.
5. Patients with BMI more than 33, those with history of drug abuse or psychological disorder and obese patients, with difficult airway or history of sleep apnoea.
6. Age <18 years and >65 years. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Prevention of rise in blood pressure and heart rate by more than 15% of baseline after injection of Dexmedetomidine 0.50 micro gram per Kg body weight 10 minutes prior to extubation.

2.Prevention of rise in blood pressure and heart rate by more than 15% of baseline after injection of Dexmedetomidine 0.25 micro gram per Kg body weight 10 minutes prior to extubation. 		 2 hour 
 
Secondary Outcome  
Outcome  TimePoints 
EXTUBATION TIME
SEDATION SCORE
 		 2 hour 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   06/12/2017 
Date of Study Completion (India) 21/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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)?  

Response - NO
Brief Summary   Laryngoscopy as well as tracheal intubation in patients undergoing surgery causes significant changes in hemodynamics . A similar type of hemodynamic derangement has been noticed by various workers during tracheal extubation. Various studies have been done on attenuation of extubation response using various drugs. The aim of the study is to define the role of dexmedetomidine with two different doses on attenuation of extubation stress response and hemodynamic changes.

 
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