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Testing Melatonin to Improve Recovery Quality After Mastoid Ear Operation.

Impact of melatonin on quality of recovery in adults undergoing mastoidectomy: A randomised placebo controlled study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/113057
Enrollment
60
Registered
2026-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: H701- Chronic mastoiditis

Interventions

Intervention1: Melatonin tablet: Patient will be given 6 milligram melatonin tablet, 1 tablet each on the night before surgery and the night after surgery. Control Intervention1: Identical looking Mul

Sponsors

All India Institute Of Medical Sciences, Deoghar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged between 18 years and 65 yrs of age belonging to ASA I and II status, undergoing elective mastoidectomy surgery

Exclusion criteria

Exclusion criteria: Patient with psychiatric or neurocognitive disorders History of alcohol or drug dependance Known sleep disturbances, with or without the use of sleep medications , current melatonin users or those with regular melatonin use within the last 4 weeks, Pregnancy or lactation, Known allergy to study drug or any condition causing significant comprehensive difficulties.

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of exogenous melatonin supplementation compared to placebo therapy on the global Qor -15 score at 24 hours postoperatively in adult patients undergoing mastoidectomy using the Hindi Qor-15 questionnaire. Timepoint: 24 hours post surgery

Secondary

MeasureTime frame
1. To analyse individual Qor-15 domain score. 2. To compare time to first rescue analgesia,total analgesic consumption between the 2 groups during the first 24 postoperative hours Timepoint: 24 hours post surgery

Countries

India

Contacts

Public ContactDrRishabh Jaju

All India institute of Medical Sciences,Deoghar

rishabh.anesthesiology@aiimsdeoghar.edu.in7742454477

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026