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Oral Melatonin premedication for decreasing preoperative anxiety in neurosurgery

Efficacy of oral melatonin premedication in reducing preoperative anxiety in patients undergoing supratentorial craniotomy - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070448
Enrollment
54
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 Control Intervention1:

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1.Preoperative anxiety score using the Amsterdam Preoperative Anxiety and Information Scale [APAIS]Timepoint: Baseline on the night before surgery and on the morning of surgery

Secondary

MeasureTime frame
Haemodynamics- Heart rate (beats per minute) and Mean arterial pressure (mmHg)Timepoint: Every 15 minutes intraoperatively;Regional cerebral oxygenation (rSO2)Timepoint: Every 15 minutes intraoperatively

Countries

India

Contacts

Public ContactHemanshu Prabhakar

All India Institute of Medical Sciences, New Delhi

prabhakaraiims@yahoo.co.in919818727319

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026