FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/069732 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effectiveness of 2 injections Dexmedetomidine and Labetalol in managing increase in blood pressure and heart rate occuring during passage of breathing tube into windpipe in patients coming for planned surgery before general anesthesia  
Scientific Title of Study   A Comparative study of dexmedetomidine and labetalol for attenuating hemodynamic response to laryngoscopy and intubation in patients coming for elective surgeries under general anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harikrishna S 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anaesthesia,Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand,Pincode-834009,India

Ranchi
JHARKHAND
834009
India 
Phone  7907217423  
Fax    
Email  harinakshatra16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen Kumar Tiwary 
Designation  Associate Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anaesthesiology RIMS Ranchi JHARKHAND 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  9661883797  
Fax    
Email  drpkt80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kumar Kharwar 
Designation  Assistant Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anaesthesiology RIMS Ranchi JHARKHAND 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  8294044274  
Fax    
Email  rameshrims02@yahoo.in  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand,pincode-834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Rajendra Institute of Medical Sciences,Bariatu,Ranchi,Jharkhand,pincode-834009 
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 Harikrishna S  Rajendra Institute of Medical Sciences  Department of anaesthesia,Bariatu,Ranchi,Jharkhand
Ranchi
JHARKHAND 		 7907217423

harinakshatra16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Rajendra Institute of Medical Sciences, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intravenous dexmedetomidine  injection Dexmedetomidine is given at a dose of 1 µg/kg in 10ml normal saline intravenously over 10 minutes 
Comparator Agent  intravenous labetalol  injection labetalol is given at a dose of 0.3 mg/kg in 10ml normal saline intravenously over 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade I & II ,Elective surgery requiring general anesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  Patient contraindicated to beta blockers,Hypertensive patients,patients on anti hypertensives,Systolic BP less than 120 mm of hg , HR less than 60/min,Evidence of anticipated difficult airway,Drug allergy to dexmedetomidine and labetalol,Pregnant patients,Ischemic heart disease,Cerebrovascular accidents,patient refusal,intubation attempts more than 2 times 
 
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 compare the efficacy of dexmedetomidine 1 µg/kg and labetalol 0.3
mg/kg in blunting the hemodynamic stress response to laryngoscopy and intubation 		 1)after drug administration
2)after induction
3)1 minute after induction
4)2 minute after induction
5)3 minute after induction
6)5 minute after induction
7)10 minute after induction
8)15 minute after induction 
 
Secondary Outcome  
Outcome  TimePoints 
1)To observe for any adverse effect related to dexmedetomidine and
labetalol
2)To determine and compare the level of sedation achieved before intubation after administration
of dexmedetomidine and labetalol 		 1)after drug administration
2)after induction
3)1 minute after induction
4)2 minute after induction
5)3 minute after induction
6)5 minute after induction
7)10 minute after induction
8)15 minute after induction 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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 3 
Date of First Enrollment (India)   31/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The process of endotracheal intubation, commonly used in various medical procedures, plays a crucial role in ensuring adequate ventilation and oxygenation of patients. However, this procedure can also induce significant physiological changes, particularly in the cardiovascular system, leading to hemodynamic instability. Understanding the hemodynamic changes during intubation is of paramount importance for healthcare professionals to effectively manage and minimize the associated risks.

General anesthesia with endotracheal intubation is very common now a days. Endotracheal intubation using direct laryngoscopes is associated with stimulation of trachea and larynx. This will result in tachycardia and rise in blood pressure .Eventhough the responses are short lived and causes less consequences in healthy patients. These changes can be fatal in patients with preexisting heart disease, hypertension or cerebrovascular condition, complications like left ventricular failure, intracranial hemorrhage and myocardial ischemia can occur as a result of tachycardia and sudden rise in blood pressure. Under such circumstances it becomes a necessity to attenuate such reflex responses associated with endotracheal intubation and laryngoscopy to achieve a balance between the myocardial oxygen supply and demand.

Common strategies include deepening the depth of anesthesia, topical anaesthesia of the oropharynx, intravenous lignocaine, intravenous fentanyl, alfentanil, sodium nitroprusside, beta adrenergic blocking drugs, alpha-2-adrenergic agonists, calcium channel blockers etc.

The advantages of Dexmedetomidine as premedicant in anaesthesia include sedation, analgesia, anxiolysis and improved hemodynamic stability. Because of these beneficial properties it has been found that minimum alveolar concentration (MAC) of volatile anaesthetic agent also decreases significantly up to 90% and hence decreases the requirement of anaesthetics.It has been found that it decrease the hemodynamic response to laryngoscopy and intubation.

Labetalol is combined α1andβ antagonist and pre induction intravenous labetalol attenuated the hemodynamic response to endotracheal intubation.Labetalol is suitable for blunting the hemodynamic changes associated with laryngoscopy and intubation

This study between comparison of IV dexmedetomidine and IV labetalol aims at finding out which drug is better at blunting the stress response associated with laryngoscopy and intubation.
 
Close