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CTRI Number  CTRI/2018/05/013835 [Registered on: 11/05/2018] Trial Registered Prospectively
Last Modified On: 11/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   use of melatonin to decrease the hemodynamic responses to laryngoscopy and intubation 
Scientific Title of Study   A prospective, randomized, double blinded study to assess the efficacy of melatonin in attenuation of hemodynamic responses to laryngoscopy and intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shilpa rajendran 
Designation  post graduate 
Affiliation  Sri Ramachandra University 
Address  A6,Department of Anesthesiology,Sri Ramachandra University,No 1 Ramachandra nagar,Porur,Chennai

Chennai
TAMIL NADU
600116
India 
Phone  04423860830  
Fax    
Email  shilpa5432@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Thamarai selvi 
Designation  Professor 
Affiliation  Sri Ramachandra University 
Address  A6,Department of Anesthesiology,Sri Ramachandra University,No 1 Ramachandra nagar,Porur,Chennai

Chennai
TAMIL NADU
600116
India 
Phone  04423860830  
Fax    
Email  thames25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thamarai selvi 
Designation  Professor 
Affiliation  Sri Ramachandra University 
Address  A6,Department of Anesthesiology,Sri Ramachandra University,No 1 Ramachandra nagar,Porur,Chennai

Chennai
TAMIL NADU
600116
India 
Phone  04423860830  
Fax    
Email  thames25@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra University,No 1,Ramachandra nagar,Porur,Chennai-600116,Tamil nadu,India 
 
Primary Sponsor  
Name  Sri Ramachandra University 
Address  Sri Ramachandra University,No 1,Ramachandra nagar,Porur,Chennai-600116,Tamil nadu,India 
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 
Shilpa Rajendran  A6 department of anesthesiology  Sri Ramachandra University,No 1,Ramachandra nagar,Porur,Chennai-600116,Tamil nadu,India
Chennai
TAMIL NADU 
04423860830

shilpa5432@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra University Institutional Research Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  decreasing laryngoscopy and intubation response in patients coming for general anesthesia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  melatonin for intubation response  melatonin 6mg tablet for reducing laryngoscopy and intubation response 
Intervention  vitamin d  similar looking placebo tablets 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Only ASA 1 and 2 patients coming for general anesthesia for surgeries longer than 30 minutes 
 
ExclusionCriteria 
Details  Diabetes
Hypertension
Psychiatric illness
Intake of anti-psychotics, sedatives, anxiolytics drugs
Sleep disorders
Allergy to study drugs
Anticipated difficult airway
Pregnant and lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
outcome-To study the changes in blood pressure in
response to laryngoscopy and intubation 
At 1,5,10 and 20 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor any adverse effects during the
study period. 
nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/05/2018 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Gupta P, Jethava D, Choudhary R, Jethava D. Role of melatonin in attenuation of hemodynamic response to laryngoscopy and intubation.IJA.October 2016;volume 60(issue 10) 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Laryngoscopy and endotracheal intubation are considered potent
noxious stimuli which provoke haemodynamic responses leading to a
marked increase in heart rate and blood pressure. These events are
especially detrimental in individuals who have limited myocardial
reserve due to coronary artery disease, cardiac dysrhythmias,
congestive heart failure, hypertension, cardiomyopathy and in the
geriatric age group. Hence, it is mandatory to take measures to
attenuate these pressor responses.

The mechanisms of these haemodynamic alterations are reflexes
due to sympathetic stimulation. During intubation of trachea, the
laryngeal and tracheal sensory receptors are stimulated which result
in the release of endogenous catecholamines resulting in tachycardia
and hypertension.
Since the invention of laryngoscopy and endotracheal intubation,
various drug regimens and techniques have been used from time to
time to attenuate these stress responses. Some of these agents
being opioids (fentanyl, alfentanil), calcium channel blockers
(verapamil, diltiazem), sympatholytics (clonidine, dexmedetomidine
and methyldopa), beta blockers (esmolol, propranolol),
benzodiazepines (midazolam, alprazolam), barbiturates, propofol,
pregabalin and peripheral vasodilators (sodium nitroprusside,
nitroglycerine).
However, each agent has its own limitations such as respiratory
depression with opioids and benzodiazepines, hypotension and
bradycardia with sympatholytics and beta blockers and so on. Hence,
there is always been a search for a ideal agent.

Melatonin (Nacetyl5methoxytryptamine) is an endogenous
sleepregulating hormone secreted by pineal gland. Exogenous
administration of melatonin facilitates sleep onset and improves the
quality of sleep. It is different from benzodiazepines and their
derivatives in that it produces natural sleep pattern and does not
lead to impairment of cognitive functions. Various researchers have
used this drug in different dose patterns as premedication in both
adults as well as children. Based on this we hypothesised that
melatonin when given before the procedure can provide
haemodynamic stability during laryngoscopy and intubation. The
primary objective is to assess the efficacy of melatonin to attenuate
the changes in blood pressure to laryngoscopy and intubation.

 
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