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CTRI Number  CTRI/2025/02/081076 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparing the effectiveness of oral Melatonin and Pregabalin in reducing blood pressure , heart rate while inserting tube during anaesthesia in patients undergoing Laparoscopic Cholecystectomy  
Scientific Title of Study   Comparative study of Melatonin versus Pregabalin in attenuation of Hemodynamic stress response to Laryngoscopy and Endotracheal intubation in Patients undergoing Laparoscopic Cholecystectomy - A Randomised Control Trial  
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 Sukhirtha S 
Designation  DNB Resident 
Affiliation  Narayana Health City 
Address  Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU Complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9842351355  
Fax    
Email  sukhirtha.s.dr@narayanahealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shwetha N Reddy 
Designation  Consultant Anaesthesiologist  
Affiliation  Narayana Health City 
Address  Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9972323333   
Fax    
Email  drshwereddy@outlook.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sukhirtha S 
Designation  DNB Resident 
Affiliation  Narayana Health City 
Address  Department of Anaesthesiology, 4th floor Anaesthesia office,B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9842351355  
Fax    
Email  sukhirtha.s.dr@narayanahealth.org  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya Hospital, Bommasandra, Bangalore , Karnataka, India Pin-560099 
 
Primary Sponsor  
Name  Narayana Hrudayalaya Hospital 
Address  Narayana Hrudayalaya Hospital, Bommasandra, Bangalore , Karnataka, India Pin-560099 
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 Sukhirtha S  Narayana Health city  Department of Anaesthesiology, 4th floor Anaesthesia office, B block OT and SICU complex,Mazumdar Shah Medical Centre, Narayana Health city,Bommasandra, Bangalore
Bangalore
KARNATAKA 
9842351355

sukhirtha.s.dr@narayanahealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NARAYANA HEALTH ACADEMIC ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Attenuation of stress response during intubation   Patients posted for laparoscopic cholecystectomy will be considered for the study. These patients will be randomly divided and Group M will be given oral Melatonin 6mg and Group P will be given oral Pregabalin 150mg 2 hours prior to the surgery. 
Comparator Agent  Melatonin   Giving Melatonin 6mg orally 2 hours prior to surgery and comparing its efficacy in reducing stress response to intubation with Pregabalin 150mg given orally 2 hours prior to surgery and monitoring blood pressure, heart rate, saturation, sedation score before , during and after intubation for 15min and one hour after extubation  
Comparator Agent  Pregabalin  Giving orally Pregabalin 150mg 2 hours prior to surgery and comparing its efficacy in reducing stress response to intubation with Melatonin 6mg given orally 2 hours prior to surgery monitoring blood pressure, heart rate, saturation, sedation score before , during and after intubation for 15min and one hour after extubation  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of American society of Anaesthesiologists (ASA) physical status Grade I, II and III 
 
ExclusionCriteria 
Details  Patients with Psychiatric illness,Sleep disorders, Drug allergy, anticipated difficult airway are excluded  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reducing stress response during Endotracheal intubation  Blood pressure, Heart rate , Mean arterial Pressure, Sedation score are monitored before, at the time and after intubation till 15 minutes and one hour post extubation  
 
Secondary Outcome  
Outcome  TimePoints 
Effect on Sedation  Pre operative & Post extubation sedation will be monitored using Ramsay sedation score 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   03/03/2025 
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  

Laryngoscopy and intubation are painful stimuli which invoke responses like tachycardia, hypertension and arrythmias. The hemodynamic stress response resulting from airway instrumentation are due to sympatho-adrenergic response caused by epi-pharyngeal and parapharyngeal stimulations which lead to rise in catecholamine level that increases blood pressure and heart rate.

          These Hemodynamic responses may be fatal in patients with coronary artery disease, hypertension, intracranial aneurysm, cerebrovascular disease and may cause MI, arrythmias, left ventricle failure and rupture of aneurysm.

         

        MELATONIN (N-acetyl-5-methoxytryptamine) is a endogenous sleep regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep and improves quality of sleep. It is different from benzodiazepines and their derivatives in that it produces natural sleep pattern and doesn’t lead impairment of cognitive functions. This drug has been mainly studied as sedative agent in intensive care unit and preoperatively as anxiolytic agent.

 

         PREGABALIN a gabapentinoid compound appears to produce an inhibitory modulation of neuronal excitability particularly neocortex, amygdala, hippocampus of CNS. It binds to the a2d subunit of voltage dependent calcium channels and inhibits the channel. It possesses analgesic, anticonvulsant and anxiolytic activity by reduction of neurotransmitter glutamate, nor-adrenaline, serotonin, dopamine and substance P.

 
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