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CTRI Number  CTRI/2018/07/014846 [Registered on: 13/07/2018] Trial Registered Prospectively
Last Modified On: 10/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATRIVE STUDY TO EVALUATE INTRAVENOUS DEXMEDETOMIDINE AND ESMOLOL FOR ATTENUATION OF HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION 
Scientific Title of Study   COMPARATRIVE STUDY TO EVALUATE INTRAVENOUS DEXMEDETOMIDINE AND ESMOLOL FOR ATTENUATION OF HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AKSHAY KALIA 
Designation  JUNIOR RESIDENT 
Affiliation  GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL 
Address  HOUSE NUMBER -,160 KRISHNA SQUARE 2 SHIVALA ROAD AMRITSAR PUNJAB
GGS medical college and hospital, faridkot , punjab
Amritsar
PUNJAB
143001
India 
Phone  8264744236  
Fax    
Email  akshaykalia91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NARESH BAGHLA 
Designation  PROFESSOR AND HEAD , DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL 
Address  HOUSE NUMBER-281,STREET NUMBER -2, GURU NANAK COLONY , FARIDKOT -
GGS MEDICAL COLLEGE AND HOSPITAL , FARIDKOT , PUNJAB ,PIN CODE -151203
Faridkot
PUNJAB
151203
India 
Phone  9814035236  
Fax    
Email  drbaghla@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR NARESH BAGHLA 
Designation  PROFESSOR AND HEAD , DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL 
Address  HOUSE NUMBER-281,STREET NUMBER -2, GURU NANAK COLONY , FARIDKOT -
GGS MEDICAL COLLEGE AND HOSPITAL , FARIDKOT , PUNJAB PINCODE-151203
Faridkot
PUNJAB
151203
India 
Phone  9814035236  
Fax    
Email  drbaghla@yahoo.com  
 
Source of Monetary or Material Support  
GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL, FARIDKOT , PUNJAB 
 
Primary Sponsor  
Name  DR AKSHAY KALIA 
Address  HOUSE NUMBER -,160 KRISHNA SQUARE 2 SHIVALA ROAD AMRITSAR PUNJAB 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
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 AKSHAY KALIA  GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL   GURU GOBIND SINGH MEDICAL COLLEGE AND HOSPITAL , FARIDKOT , PUNJAB
Faridkot
PUNJAB 
8264744236

akshaykalia91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THESIS AND ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  IN PATIENTS UNDERGOING GENERAL ANAESTHESIA WITH LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  TO EVALUATE INTRAVENOUS DEXMEDETOMIDINE FOR ATTENUATION OF HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION 
Intervention  ESMOLOL  TO EVALUATE INTRAVENOUS DEXMEDETOMIDINE AND ESMOLOL FOR ATTENUATION OF HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 American Society of Anaesthesiologists Grade I and II patients.
2 Patients scheduled for elective surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  American Society of Anaesthesiologists Grade 3 and 4 patients
Pregnant patients
Refusal of the patient 
 
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 
HAEMODYNAMIC RESPONSE   TIME WILL BE NOTED BEFORE , DURING , AFTER 1, 2, 4, 6, 8 AND 10 MIN OF INTUBATION 
 
Secondary Outcome  
Outcome  TimePoints 
HAEMODYNAMIC OUTCOME  TIME WILL BE NOTED BEFORE , DURING , AFTER 1, 2, 4, 6, 8 AND 10 MIN OF INTUBATION 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   20/07/2018 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   11. Khan ZP, Ferguson CN, Jones RM. Alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia 1999;54:146-165. 12. Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol 2011;27(3):297–302.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

COMPARATIVE STUDY TO EVALUATE INTRAVENOUS DEXMEDETOMIDINE AND ESMOLOL FOR ATTENUATION OF HAEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION

Candidate: Dr. Akshay Kalia

Supervisor:                                               Co-Supervisor:

 

 

Dr.Naresh Baghla                                    Dr. Gurpreet Singh

Head of the Department                              Professor,

Dept. of Anaesthesiolgy,                           Dept. of Anaesthesiology     

G.G.S. Medical College,                               G.G.S. Medical College,

Faridkot.                                                 Faridkot.

INTRODUCTION : Securing a patent airway is of paramount importance in the management of any safe anesthetic procedure and it is one of the primary goals of an anaesthesiologist during general anaesthesia Though endotracheal intubation is a perfect airway device yet its placement isknown to evoke the stress response, predominantly in the form of tachycardia and systemic hypertension, exposing the patient to unwanted risk The topic of study will be selected because tachycardia and hypertension may getfurther enhanced in response, to laryngoscope and tracheal intubation, proven dangerous to cardiovascular disease patients.

AIMS AND OBJECTIVESThe present study will be designed 1. to evaluate the effects of Intravenous Dexmedetomidine and esmolol  in attenuating the hemodynamic responses during laryngoscopy and endotracheal intubation. 2. to compare the effects of Intravenous Dexmedetomidine and esmolol  in attenuating the hemodynamic responses during laryngoscopy and endotracheal intubation

MATERIALS AND METHODS : The present study will be conducted in a randomized manner in the department of Anaesthesiology, GGS Medical College and hospital,Faridkot on 210 adults participants of ASA Grade I & II, aged 18-60 years, schedule to undergo elective surgery under general anaesthesia, will be  randomly allocated to either of the three study groups.GROUP C – will receive 20ml of 0.9% Normal saline infused over a period of 10 min and induction of anaesthesia will be done immediately.GROUP D – will receive Dexmedetomidine 1μ/kg intravenous diluted with 0.9%  normal saline to 20 ml infused over 10 min and induction of anaesthesia will be done immediately.GROUP E – will receive Esmolol 1.5mg/kg intravenous diluted  with 0.9% normal saline to 20ml  infused over 10 min  and induction of anaesthesia will be done immediately.

 

 
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