| 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
|
|
|
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
|
|
|
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. |