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

Not Applicable

Completed

• Conditions: Delirium, Anesthesia Emergence; Delirium
• Interventions: Other: No intervention; Drug: Midazolam; Drug: Melatonin

• Registration Number: NCT05236907
• Lead Sponsor: University of Baghdad

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-01
• Study First Submitted: 2022-01-06
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-02
• Last Update Submitted: 2022-02-02
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	No intervention	Patients in this group received nothing for sedation.
Midazolam group	Midazolam	7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.
Melatonin group	Melatonin	5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively

Primary Outcome Measures

Name	Time	Method
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia	1 week	This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.

Trial Locations

Locations (2)

Al-Kadhemya Private Hospital; 🇮🇶 Baghdad, Iraq

Ghazi Al-Hariri Teaching Hospital; 🇮🇶 Baghdad, Iraq