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CTRI Number  CTRI/2024/03/064813 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Single Arm Study 
Public Title of Study   To Check the effectiveness of three different doses of Fentanyl Citrate for reduce the cardiovascular stress response to Laryngoscopy and Endotracheal Intubation in surgeries under General Anaesthesia - A Randomised Comparative Study. 
Scientific Title of Study   Efficacy of three different doses of Fentanyl Citrate for attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation in surgeries under General Anaesthesia - A Randomised Comparative Study. 
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 Dielle Jade Martins 
Designation  Post graduate resident in Anaesthesia  
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital  
Address  Room no.1712 B block Department of Anaesthesia, PGI building ABVIMS and Dr RML Hospital New Delhi 110001 India

Central
DELHI
110001
India 
Phone  9561067326  
Fax    
Email  Diellem777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalita Chaudhary  
Designation  Director Professor 
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital  
Address  Room no. 301 Department of Anaesthesia PGI building ABVIMS and Dr RML Hospital New Delhi 110001 India

Central
DELHI
110001
India 
Phone  9968299710  
Fax    
Email  lalitachaudhary055@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lalita Chaudhary  
Designation  Director Professor 
Affiliation  ABVIMS and Dr Ram Manohar Lohia Hospital  
Address  Room no. 301 Department of Anaesthesia PGI building ABVIMS and Dr RML Hospital New Delhi

Central
DELHI
110001
India 
Phone  9968299710  
Fax    
Email  lalitachaudhary055@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi  
 
Primary Sponsor  
Name  ABVIMS and Dr Ram Manohar Lohia Hospital 
Address  ABVIMS and Dr RML Hospital Baba Kharak singh marg New Delhi India 110001 
Type of Sponsor  Research institution and hospital 
 
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 Dielle Jade Martins  ABVIMS and Dr.Ram Manohar Lohia Hospital   room no. 301 Department of Anaesthesia ABVIMS and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib , Connaught Place , New Delhi, 110001
Central
DELHI 		 9561067326

Diellem777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, ABVIMS, Dr RML Hospital, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K460||Unspecified abdominal hernia withobstruction, without gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  American Society Of Anaesthesiologists [ASA] physical status I and II patients.
Elective surgical procedure of more than 3 hours. 
 
ExclusionCriteria 
Details  1.Known sensitivity to any study drug.

2.Pregnant females.

3.Patient with chronic Hypertension and Diabetes Mellitus.

4.Patient with history of cardiac or respiratory disease.

5.Patient with anticipated difficult airway.

6.Patient with impaired kidney or liver function.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic parameters to Laryngoscopy and Endotracheal Intubation (HR, SBP, DBP, MAP).  Hemodynamic parameters to Laryngoscopy and Endotracheal Intubation (HR, SBP, DBP, MAP) at 1 min, 3 min and 5 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical markers of stress response ( SERUM CORTISOL AND BLOOD GLUCOSE LEVELS ).  Pre op and 5 mins after intubation  
 
Target Sample Size   Total Sample Size="111"
Sample Size from India="111" 
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)   03/04/2024 
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="4"
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  

Securing the airway is an essential component of anaesthesia care for patients undergoing surgeries under General Anaesthesia. Laryngoscopy and Endotracheal Intubation are core integral components of anaesthetic management under General Anaesthesia but these are associated with reflex cardiovascular responses mediated by sympathetic nervous system by stimulating sympathoadrenal receptors releasing catecholamines in the blood thus transiently causing tachycardia, hypertension, arrhythmias and raised intraocular and intracranial       pressures. Such pressor responses are well tolerated in healthy individuals but are hazardous in patients suffering from coronary artery disease, hypertension, valvular heart disease, stroke, intracranial lesions and penetrating eye injuries.

Several measures have been shown for attenuation of hemodynamic stress response to laryngoscopy and Endotracheal intubation including deepening the plane of anaesthesia, limiting the duration of Laryngoscopy for <30 seconds, various pharmacological measures such as Opioids like Fentanyl ,Vasodilators, Beta Blockers( selective and non selective), Calcium channel blockers, Lignocaine , Magnesium Sulphate etc. Among these, Fentanyl belongs to the phenylpiperidine group of synthetic opioids and is a opioid agonist at Âµ1 and Âµ 2 receptors with rapid onset of action peak of about 5 mins and rapid termination of its effects after a single dose and the occurrence of relative cardiovascular stability and has been shown to effectively attenuate hemodynamic stress response to Laryngoscopy and Endotracheal intubation. Fentanyl decreases the heart rate by increasing Vagal tone by stimulating Vagal nuclei in the medulla thereby, preventing hemodynamic stress response to Laryngoscopy and Endotracheal Intubation .

          

It also dilates arterial and venous blood vessels through a central mechanism,by primarily slowing down vasomotor centers in the brain. Recent assays in man show no clinically significant histamine release in dosages up to 50mcg/kg. Total moderate dose of Fentanyl Citrate in adults for General anaesthesia is 2-20mcg/kg.

   We devised this study to evaluate the efficacy of three different doses of Fentanyl Citrate for  

   attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation.

 
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