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CTRI Number  CTRI/2024/07/070106 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   How melatonin helps manage Blood pressure and Heart Rate during laryngoscopy and endotracheal intubation 
Scientific Title of Study   Effects of melatonin premedication on the hemodynamic responses and perfusion index during laryngoscopy and endotracheal intubation-A Randomized control 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 Manjunath Pirappa Dali 
Designation  Post Graduate Resident 
Affiliation  Bangalore Medical College And Research Institute Bengaluru 
Address  Department of Anaesthesiology Bangalore medical college And Research Institute Bengaluru
DEPT OF ANAESTHESIOLOGY BMC AND RI
Bangalore
KARNATAKA
560002
India 
Phone  09663337565  
Fax    
Email  manjunathpdali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Bharathi B M 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College And Research Institute Bengaluru 
Address  Department of Anaesthesiology Bangalore Medical College And Research Institute Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9842441267  
Fax    
Email  doc.blossoms@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Bharathi B M 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College And Research Institute Bengaluru 
Address  Department Of Anaestesiology Bangalore Medical College And Research Institute Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9842441267  
Fax    
Email  doc.blossoms@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College And Research Institute 
 
Primary Sponsor  
Name  Bangalore Medical College And Research Institute Bengaluru 
Address  Fort K R Road Kalasipalya Bengaluru Karnataka 560002 
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 Manjunath Pirappa Dali  Bangalore Medical College And Its Attached Hospitals  Department Of Anaesthesiology
Bangalore
KARNATAKA 		 9663337565

manjunathpdali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College And Research Institute  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  Administration of oral melatonin 6mg and 9mg prior to surgery  Dose of the drug for group 6 mg and another 9mg by oral route intervention duration is 1hr record of haemodynamic parameters before during and after laryngoscopy and tracheal intubation 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1)Patients belonging to the American Society of Anaesthesiologists physical status grade 1 & 2
2) Surgery requiring general anaesthesia for duration for longer than 30 min.
3)Patients who are willing to give inform consent 
 
ExclusionCriteria 
Details  1)Patients having uncontrolled diabetes,hypertension,psychiatric illness,intake of antipsychotics,sedatives,anxiolytics and antiepileptics drugs;sleep disorders.
2)Patients with obesity
3)Patients having drug allergy.
4)Patient with anticipated difficult intubation
5)Patients requiring more than one attempt or more than 20s for laryngoscopy
6)Patient refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Primary outcome for this study is likely the change in the hemodynamic responce,which includes measurment such as blood pressure and heart rate,during laryngoscopy and endotracheal intubation following melatonin premedication..  Hemodynamic parameters taken at prior medication,baseline ,just before intubation after intubation,5min,10min,15min  
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of adverse effects related to melatonin premedication.
2.level of sedation or anxiety in patients before the procedure.
3.ease of intubation as assessed.
4.Recovery time after the procedure. 		 Before administration baseline measurement,before procedure ,during laryngoscopy & endotracheal intubation ,immediately after procedure,30min to 1 hr(to assess short term recovery)  
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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 2/ Phase 3 
Date of First Enrollment (India)   09/07/2024 
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="0"
Months="6"
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   Several techniques have been proposed to prevent or attenuate the hemodynamic responses following laryngoscopy and intubation , preoperative melatonin has a significant analgesic and anxiolytic effect for patients undergoing surgery. Endotracheal intubation is one of the most invasive stimuli in anaesthesia particularly during induction and after tracheal intubation. It is usually well tolerated by normotensive patients ,but even short-lasting stimulation has been associated with increased morbidity and mortality in patients with recent myocardial infarction, hypertension, pre-eclampsia and cerebrovascular pathology such as tumors, aneurysms or increased intracranial pressure. Stress response  increases both SBP and DBP measurements increase by 36-40% in contrast to control levels .Heart rate levels increase more than 20% with tracheal intubation in contrast to laryngoscopy. The pressor (stress) response reaches a peak 1-2 min after laryngoscopy and tracheal intubation, and usually subsides within 5-6 min ,although tachycardia may persist for 10min .Studies in humans indicate that 1mg 0f melatonin increases arterial pressure and the plasma levels of noradrenaline during standing .
             Melatonin (N-acetyl -5-methoxytryptamine) is an endogenous sleep-regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep onset and improves the quality of sleep .it 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 adult as well children. It has been mainly studied in view of preoperative anxiolysis, sedation in intensive care unit, preoperative cognitive and psychomotor functions.
        The current study aimed at assessing the usefulness of melatonin in attenuating the pressor response to direct laryngoscopy and tracheal intubation.
and preop anxiety and post op sedation using different doses of melatonin.
 
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