The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

University of Baghdad

Status: Completed

Conditions: Delirium; Delirium, Anesthesia Emergence

Treatments: Drug: Melatonin; Drug: Midazolam; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05236907

Melatonin123

Details and patient eligibility

About

Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.

Full description

Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.

Enrollment: 36 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1- Patients in good general health. 2. Baseline MDAS <13. 3. No seizure disorder.

Exclusion criteria

1. Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
2. Patients with a history of acute or chronic confusion.
3. Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
4. Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Patients in this group received nothing for sedation.

Treatment:

Other: No intervention

Midazolam group

Active Comparator group

Description:

7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.

Treatment:

Drug: Midazolam

Melatonin group

Experimental group

Description:

5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively

Treatment:

Drug: Melatonin