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CTRI Number  CTRI/2020/10/028693 [Registered on: 28/10/2020] Trial Registered Prospectively
Last Modified On: 16/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This is a study to compare the effects of three drugs which are intravenous Dexmedetomidine, Magnesium Sulphate and Esmolol in reducing the stress response during laryngoscopy and endotracheal intubation during general Anaesthesia 
Scientific Title of Study   Comparison of intravenous Dexmedetomidine, Magnesium Sulphate and Esmolol on the attenuation of pressor stress 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  KAJOL AGGARWAL 
Designation  PG STUDENT 
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS 
Address  DEPARTMENT OF ANAESTHESIA, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS, BAHADUR SHAH ZAFAR MARG, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9899374284  
Fax    
Email  kajol.aggarwal11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  LALITA CHAUDHARY 
Designation  CONSULTANT DOCTOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS 
Address  B L TANEJA BLOCK, DEPARTMENT OF ANAESTHESIA, MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9968299710  
Fax    
Email  lalitachaudhary055@gmail.com  
 
Details of Contact Person
Public Query  
Name  KAJOL AGGARWAL 
Designation  PG STUDENT 
Affiliation  MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS 
Address  DEPARTMENT OF ANAESTHESIA, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS, BAHADUR SHAH ZAFAR MARG, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9899374284  
Fax    
Email  kajol.aggarwal11@gmail.com  
 
Source of Monetary or Material Support  
MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  MAULANA AZAD MEDICAL COLLEGE, BAHADUR SHAH ZAFAR MARG, NEW DELHI 110002 
Type of Sponsor  Government medical college 
 
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 
KAJOL AGGARWAL  MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS  DEPARTMENT OF ANAESTHESIA BL TANEJA BLOCK, BAHADUR SHAH ZAFAR MARG, NEW DELHI
New Delhi
DELHI 		 9899374284

kajol.aggarwal11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAULANA AZAD MEDICAL COLLEGE  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 
Comparator Agent  Administration of intravenous dexmedetomidine, magnesium sulphate and esmolol before laryngoscopy and endotracheal intubation.  comparing the blood pressure, heart rate, serum cortisol and blood glucose levels before and after intubation. 
Intervention  Administration of intravenous dexmedetomidine, magnesium sulphate and esmolol.  administration of intravenous dexmedetomidine, magnesium sulphate ans esmolol before laryngoscopy and endotracheal intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA.
2. AMERICAN SOCIETY OF ANAESTHESIOLOGISTS PHYSICAL STATUS I AND II PATIENTS. 
 
ExclusionCriteria 
Details  1. PATIENTS WITH KNOWN SENSITIVITY TO ANY STUDY DRUG.
2. PREGNANT FEMALES.
3. PATIENTS WITH CHRONIC HYPERTENSION AND DIABETES MELLITUS.
4. PATIENTS WITH HISTORY OF CARDIAC OR RESPIRATORY ILLNESS.
5. PATIENTS WITH ANTICIPATED DIFFICULT AIRWAY.
6. PATIENTS WITH IMPAIRED KIDNEY OR LIVER FUNCTION. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE, MAGNESIUM SULPHATE AND ESMOLOL FOR ATTENUATION OF PRESSOR RESPONSE(HEART RATE AND BLOOD PRESSURE) TO DIRECT LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION.  AT THE TIME OF ARRIVAL IN THE OPERATING ROOM, AND AT 1 MINUTE, 3 MINUTE, 5 MINUTE AND 10 MINUTE AFTER INTUBATION.  
 
Secondary Outcome  
Outcome  TimePoints 
COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE, MAGNESIUM SULPHATE AND ESMOLOL FOR ATTENUATION OF METABOLIC STRESS RESPONSE(SERUM CORTISOL AND BLOOD GLUCOSE) TO DIRECT LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION.  AT THE TIME OF ARRIVAL IN THE OPERATING ROOM AND 10 MINUTES AFTER INTUBATION. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/11/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Securing the airway is an essential component of anaesthesia care for patients undergoing surgery under general anesthesia. Maneuvers such as laryngoscopy and endotracheal intubation are noxious stimuli associated with certain cardiovascular changes such as tachycardia, rise in blood pressure and various types of cardiac arrhythmias. These hemodynamic changes are due to sympathoadrenal discharge caused by epipharyngeal and parapharyngeal stimulations. This can lead to various adverse events like myocardial ischemia, pulmonary edema, acute heart failure and cerebrovascular accidents in susceptible individuals. Various drugs like lignocaine, opioid analgesics, benzodiazepenes, beta blockers, alpha adrenergic blockers, calcium channel blockers and vasodilators have been tried with variable success to attenuate this stress response and provide haemodynamic stability perioperatively.

Dexmedetomidine is a highly selective α2 adrenergic agonist which provides anxiolysis, sedation, cardiovascular stability, analgesia, anterograde amnesia and decreased exocrine secretions and thereby prevents hypertension and tachycardia.

Magnesium sulphate is a calcium antagonist and can modify many calcium-mediated responses. It’s a cerebral depressant which acts by blocking the N-methyl-D-aspartate(NMDA) receptors and also decreases the sympathetic outflow.

Esmolol is an ultra-short acting cardioselective β-blocker with rapid onset which makes it an attractive option for attenuating the pressor and metabolic response to laryngoscopy and intubation. So, we aim to compare Dexmedetomidine, Magnesium Sulphate and Esmolol in the attenuation of pressor stress response to laryngoscopy and endotracheal intubation.

 
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