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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium, Anesthesia Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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Study Groups

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Control Group

Patients in this group received nothing for sedation.

Group Type PLACEBO_COMPARATOR

No intervention

Intervention Type OTHER

No intervention was used.

Midazolam group

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

7.5 mg of Midazolam orally.

Melatonin group

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

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

No intervention

No intervention was used.

Intervention Type OTHER

Midazolam

7.5 mg of Midazolam orally.

Intervention Type DRUG

Other Intervention Names

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Midazolam

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No