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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05236907
Enrollment
36
Registered
2022-02-11
Start date
2020-07-01
Completion date
2020-11-01
Last updated
2022-02-11

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

Conditions

Delirium, Delirium, Anesthesia Emergence

Keywords

Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively

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.

Interventions

DRUGMelatonin

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.

OTHERNo intervention

No intervention was used.

DRUGMidazolam

7.5 mg of Midazolam orally.

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

It has been done on all the study's contributors and workers.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia1 weekThis interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026