Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Intervention1: Group A (Dual-Dose): Oral melatonin 3 mg at 10 PM the night before surgery and 3 mg
120 minutes before induction of anaesthesia.
Control Intervention1: Group B (Single-Dose): Oral placebo at 10 PM on night before surgery and oral melatonin 3 mg
120 minutes before induction of anaesthesia.
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Asa 1 and 2, Vas score baseline more than or equal to 4, scheduled laparoscopic surgeries whose duration less than 3 hours.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria; use of sedatives, anti depressants, or melatonin within the past 2 weeks, history of psychiatric illness or sleep disorders, substance abuse (past or present), known allergy or contraindication to melatonin, pregnant or lactating women, Body Mass Index (BMI) > 35 Kg/m2, Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare preoperative anxiety levels using the Visual Analogue Scale for Anxiety (VAS-A). Timepoint: At baseline preoperatively, and 90 minutes after administration of the morning dose of melatonin between dual dose and single dose melatonin groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate postoperative recovery using the Hindi version of the Quality of Recovery-15 (QoR-15) questionnaire 2 To compare preoperative sedation levels before shifting the patient to the operation theatre assessed using the Ramsay Sedation Scale (RSS) 3 To evaluate intraoperative haemodynamic parameters (HR, SBP, DBP, MAP) recorded at 15-minute intervals 4 To compare perioperative analgesic requirements, including total intraoperative & postoperative opioid consumption 5 To assess patient satisfaction using a 5-point Likert scale in Hindi language.Timepoint: 1 Measure postoperative recovery using tQoR-15 on postoperative Day 1 or before discharge from the hospital. 2 Preoperative sedation before induction using the RSS 3 Measurement of parameters (HR, SBP, DBP, MAP) at 15-minute intervals intraoperatively. 4 Measurement of analgesic requirements within the first 24 hr postoperatively. 5 Measure patient satisfaction using a 5-point Likert scale recorded at 24 hr postoperatively | — |
Countries
India
Contacts
Public ContactHARIHARAN J
AIIMS New Delhi
Outcome results
None listed