Evaluation of the effect of melatonin in preventing delirium in patients after neurosurgery

Evaluation of the effect of oral melatonin administration in preventing delirium in patients after neurosurgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211211053353N1

Enrollment

Registered

2022-01-12

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

delirium. Delirium is?characterized?by a disturbance of attention, orientation, and awareness that develops within a short period of time, with transient symptoms that may fluctuate depending on the underlying causal condition or etiology. Delirium often includes d

Interventions

Intervention 1: Intervention group: Melatonin, 5mg, twice: the night before surgery and 90 minutes before surgery, taken orally. Intervention 2: Control group: placebo.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing degenerative spine surgery.

Exclusion criteria

Exclusion criteria: Patients with a history of alcoholism Dementia Patients with brain accidents such as stroke, bleeding, infection Taking medications such as:Anticonvulsants / Antidepressants / Antihistamines / Parkinson's / Antipsychotics / Benzodiazepines

Design outcomes

Primary

Measure	Time frame
Percentage of people who develop delirium after neurosurgery. Timepoint: After surgery and 1,2,3 days after surgery. Method of measurement: questionnaire Confusion Assessment Method for the ICU (CAM-ICU).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefeh Karimi

Tehran University of Medical Sciences

ati.karimi97@gmail.com+98 21 5597 5268

Outcome results

None listed

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