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To study effect of melatonin in patients who are undergoing nose surgery the effect of preventing agitation.

Effect of oral melatonin premedication on emergence agitation after nasal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052989
Enrollment
102
Registered
2023-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: J329- Chronic sinusitis, unspecified Health Condition 2: J339- Nasal polyp, unspecified

Interventions

Intervention1: Melatonin 5 mg: Melatonin 5 mg given orally Once 90 minutes before the proposed surgical procedure Control Intervention1: Placebo (similar looking pill): Placebo administered Once 90 mi

Sponsors

MS Ramaiah Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 20-65 years Patients undergoing nasal surgeries under general anaesthesia and requiring nasal packing after surgery

Exclusion criteria

Exclusion criteria: BMI greater than or equal to 30 kg/m2 Uncontrolled hypertension or diabetes mellitus Uncontrolled asthma or COPD Ischemic heart disease or other cardiac disorders Kidney or liver diseases Cognitive impairment Chronic use of antipsychotic medications or substance use disorder Pregnancy

Design outcomes

Primary

MeasureTime frame
Emergence Agitation as assessed by Ricker sedation agitation scaleTimepoint: Emergence Agitation will be assessed 2 minutes after extubation

Secondary

MeasureTime frame
Sedation as assessed by Modified Ramsay sedation scaleTimepoint: 5 minutes before administering general anaesthesia;Time to verbal responseTimepoint: Time in minutes for patient to respond to verbal commands after discontnuation of anaesthetics will be noted (as soon as patient opens his/her eyes to verbal request)

Countries

India

Contacts

Public ContactDr Tejesh C A

MS Ramaiah Medical College

drtejeshca@yahoo.com9886481848

Outcome results

None listed

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