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
|
|
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
|
|
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. |