The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- No intervention
- Conditions
- Delirium, Anesthesia Emergence
- Sponsor
- University of Baghdad
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Hashim Talib Hashim
Principal Investigator
University of Baghdad
Eligibility Criteria
Inclusion Criteria
- •1- Patients in good general health.
- •Baseline MDAS \<
- •No seizure disorder.
Exclusion Criteria
- •Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
- •Patients with a history of acute or chronic confusion.
- •Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
- •Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).
Arms & Interventions
Control Group
Patients in this group received nothing for sedation.
Intervention: No intervention
Midazolam group
7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.
Intervention: Midazolam
Melatonin group
5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively
Intervention: Melatonin
Outcomes
Primary Outcomes
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
Time Frame: 1 week
This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.