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CTRI Number  CTRI/2024/07/070448 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 18/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Oral Melatonin premedication for decreasing preoperative anxiety in neurosurgery 
Scientific Title of Study   Efficacy of oral melatonin premedication in reducing preoperative anxiety in patients undergoing supratentorial craniotomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chandini K 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology, CN Centre, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  919361419889  
Fax    
Email  chandiniamar01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Hemanshu Prabhakar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology, CN Centre, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  919818727319  
Fax    
Email  prabhakaraiims@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Hemanshu Prabhakar 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Neuroanaesthesiology, CN Centre, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  919818727319  
Fax    
Email  prabhakaraiims@yahoo.co.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi 
Address  AIIMS, Ansari Nagar, Delhi - 110029 
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 Chandini K  All India Institute of Medical Sciences, Delhi  Department of Neuroanaesthesiology,CN Centre, AIIMS , New Delhi
South
DELHI 
919361419889

chandiniamar01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe - AIIMS Delhi  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  Oral Melatonin Premedication  Oral Melatonin 6 mg will be administered as premedication on the day of surgery, 90 minutes before shifting to the operation theatre 
Comparator Agent  Placebo  Oral placebo will be administered 90 minutes before the surgery as premedication 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Written Consent 2. Supratentorial craniotomy for tumor less than 5 cm 3. ASA 1 and 2 4. Duration of surgery less than 4 hours and duration of anaesthesia less than 6 hours 
 
ExclusionCriteria 
Details  1. Patient’s refusal 2. Pregnancy 3. BMI more than 35 kg/m2
d. Patients who had sensitivity to the study drug
e. Patients with deranged liver and renal functions
f. American Society of Anaesthesiologists Class III and IV
g. Previous history of craniotomy or any intracranial procedure
h. Patients with altered sensorium
i. Patients with midline shift of more than 5 mm on radiological imaging
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Preoperative anxiety score using the Amsterdam Preoperative Anxiety and Information Scale [APAIS]  Baseline on the night before surgery and on the morning of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamics- Heart rate (beats per minute) and Mean arterial pressure (mmHg)  Every 15 minutes intraoperatively 
Regional cerebral oxygenation (rSO2)   Every 15 minutes intraoperatively 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/07/2024 
Date of Study Completion (India) 01/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/08/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

In the preoperative period, a written informed consent from the patient or their kins will be obtained after a detailed explanation of the study. Randomisation of subjects into 2 groups will be done using a computer-based simple randomisation method. Allocation concealment will be done using a serially numbered opaque sealed envelope technique. During the pre-anaesthetic check-up on the day before surgery, the APAIS anxiety score will be evaluated and noted (X1). On the day of surgery, after an adequate fasting period, the patient will be administered Tab. Melatonin 6 mg with sips of water in the study group (M) or a placebo in the control group (C). Ninety minutes before shifting to OT, the study drug would be given by a qualified health care personnel [nurse] to whom the opaque sealed envelope will be given. Before shifting inside OT, APAIS will be assessed again (X2). Inside the operation theatre, standard ASA monitoring (5 lead electrocardiograph (ECG), non-invasive blood pressure (NIBP), and pulse oximeter (SpO2) along with cerebral oximeter and nasopharyngeal temperature probe will be attached. Baseline blood pressure, pulse and regional cerebral saturation (rSO2) will be recorded. After induction of anaesthesia and intubation, vitals will be recorded every 15 minutes. Anaesthesia will be maintained with air/oxygen mixture (1:1) at flow rate of 2 litres/min along with fentanyl infusion 1 mcg/kg/hr and Propofol infusion 100 mcg/kg/min, titrated to effect. Intraoperative neuromuscular blockade will be maintained with rocuronium 0.2 to 0.3 mg/kg/hr infusion. Before the opening of dura, 20% mannitol at a dose of 1 g/kg will be infused over 20 minutes in all patients. Throughout the surgery End tidal CO2 will be maintained in the range of 30-35 mmHg. At the completion of surgery, time to emergence and time to extubation will be recorded after administration of reversal agent. Patients not extubated for any reason will be excluded from the study.

 
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