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CTRI Number  CTRI/2021/06/034181 [Registered on: 11/06/2021] Trial Registered Prospectively
Last Modified On: 10/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the Efficacy of IV Esmolol VS IV Dexmedetomidine in blocking pressor response to Laryngoscopy and Intubation in Patients undergoing Elective Major Surgeries.  
Scientific Title of Study   Comparison of Efficacy of IV Esmolol VS IV Dexmedetomidine in Attenuation of Sympathomimetic response to Laryngoscopy and Intubation in Patients undergoing Elective Major Surgeries. A prospective, double-blind, randomized controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arundhati Chadha 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical sciences, Raipur 
Address  Department of Anaesthesiology, B-Block fourth floor OT complex, AIIMS raipur, GE road, Tatibandh, Raipur, Chhattisgarh.

Raipur
CHHATTISGARH
492099
India 
Phone  8178937529  
Fax    
Email  arundhatichadha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subrata Kumar Singha 
Designation  Professor, Anaesthesiology. 
Affiliation  All India Institute of Medical sciences, Raipur 
Address  B-Block, Super Specialty OT, Department of Anaesthesiology, AIIMS Raipur, Chhattisgarh.

Raipur
CHHATTISGARH
492099
India 
Phone  8518881767  
Fax    
Email  subratsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arundhati Chadha 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical sciences, Raipur 
Address  Department of anaesthesiology, B Block fourth floor OT complex, AIIMS raipur, GE road, Tatibandh, Raipur, Chhattisgarh.

Raipur
CHHATTISGARH
492099
India 
Phone  8178937529  
Fax    
Email  arundhatichadha@gmail.com  
 
Source of Monetary or Material Support  
All India institute of Medical Sciences, Raipur. 
 
Primary Sponsor  
Name  Dr Arundhati Chadha 
Address  Department of Anaesthesiology, B Block fourth floor OT complex, AIIMS raipur, GE road, Tatibandh, Raipur, Chhattisgarh. 
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 Arundhati Chadha  AIIMS, Raipur  Department of Anaesthesiology, operation theatres.
Raipur
CHHATTISGARH 		 8178937529

arundhatichadha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Raipur  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administration of Efficacy of either IV Esmolol or IV Dexmedetomidine in Patients undergoing Elective Major Surgeries.  Administration of either IV Esmolol or IV Dexmedetomidine to compare their efficacy in Attenuating Sympathomimetic response to Laryngoscopy and Intubation in Patients undergoing Elective Major Surgeries. 
Intervention  Group A- Patients receiving Esmolol 2mg/kg IV Infusion over 10 minutes. Group B- Patients receiving Dexmedetomidine 1mcg/kg IV Infusion over 10 minutes.  The study drugs (Esmolol 2 mg/kg or Dexmedetomidine 1 mcg/kg) will be prepared in identical 20 ml syringes, diluted to a total volume of 20 ml with 0.9% normal saline, to be infused via identical syringe pumps over a period of 10 mins to suppress laryngoscopic response. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing Elective Major surgeries,
Patient related factors,
1. Adults between 30 to 65 yrs.
2. BMI between 18.5 to 30 kg per m2 .
3. Mallampati Airway class I and II.
4. ASA I, II and III patients.
Surgery related factors,
1. Operative time more than 4 hours.
2. Expected Excessive intra operative blood loss.
3. Expected peri operative blood transfusion of more than or equal to 2 PRBC.
4. And, or one of the following surgeries,
i. Radical hysterectomy.
ii. TURP.
iii. Discectomy, Laminectomy.
iv. Thyroidectomy.
v. lung operations.
vi. Ileostomy, colectomy.
vii. Neck lymph node dissection.
viii. Neurosurgeries.
ix. Heart surgeries. 
 
ExclusionCriteria 
Details  1. Unwillingness to give consent.
2. Allergy to any of the drugs.
3. Anticipated Difficult Airway.
4. Intubation attempts lasting for more than 30 secs.
5. Left ventricular ejection fraction less than 45 percent.
6. Pregnant and lactating females.
7. Acute or Chronic Renal Disease.
8. Acute or Chronic Liver Disease.
9. Chronic Obstructive Pulmonary Disease.
10. ASA IV, V and VI patients. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Primary Outcome measure - Heart rate, Systolic Blood pressure,
Diastolic Blood Pressure, Mean arterial Pressure. 		 At Baseline, At each minute of Study Drug Infusion for 10 mins, During
Intubation, After Intubation, At each minute for 10
minutes, At 15 mins, 30 mins and 1 hour after intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Bi spectral Index (BIS %)  Baseline,
after study drug infusion/immediately after induction (SDI at
10mins),
During laryngoscopy and Intubation (DI),
After intubation
(AI-0-10) at each minute for 10 mins, During skin incision,
At 15 mins, 30 mins and 1 hour after intubation. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/06/2021 
Date of Study Completion (India) 27/12/2021 
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   not yet applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arundhatichadha@gmail.com].

  6. For how long will this data be available start date provided 22-09-0001 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Laryngoscopy and endotracheal intubation during general anesthesia causes significant hemodynamic disturbance due to stimulation of the sympathoadrenal system. For patients undergoing Major surgeries, tachycardia and hypertension due to the stress of laryngoscopy and intubation increases the risk of perioperative myocardial ischemia and infarction.
Esmolol is an ultra-short acting beta-adrenergic receptor antagonist which minimizes the increase in HR and myocardial contractility by attenuating the positive chronotropic and inotropic effects of increased adrenergic activity, without significant adverse effects.
Dexmedetomidine is an imidazole derivative and highly selective alpha2-adrenergic receptor agonist, which also decreases HR and Bood pressure with additional dose-dependent sedation, anxiolysis and analgesia due to its effect on the central adrenergic outflow.
Also, the effects of laryngoscopy and intubation on changes in the bi spectral index (BIS) are unclear.
We by means of this study, aim to compare the efficacy of these two drugs in attenuating this pressor response, even though short lived, to laryngoscopy and intubation, which may otherwise prove detrimental to patients in these patients. And to also note the effect of laryngoscopy and intubation on BIS and see whether or not the drugs used to suppress pressor response have any effect on BIS variations, if any, too.
 
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