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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236907
• Other study ID #: Melatonin123
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: February 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 1, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Drug:
• Melatonin
The patients were assessed using the Memorial Delirium Assessment Scale (MDAS) after the operation at 30, 60, and 90 min. Melatonin was shown to reduce delirium from 41.6% to 16.6% at 60 minutes, and the significant reduction was at 90 minutes (0%) when compared to both groups. Thus, melatonin was found to be successful in decreasing postoperative delirium when administered preoperatively.

Other:
• No intervention
No intervention was used.

Drug:
• Midazolam
7.5 mg of Midazolam orally.

Locations

Country	Name	City	State
Iraq	Al-Kadhemya Private Hospital	Baghdad
Iraq	Ghazi Al-Hariri Teaching Hospital	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia	This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.	1 week