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

Sponsor

University of Baghdad (Other)

Overall Status

Completed

CT.gov ID

NCT05236907

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium, Anesthesia Emergence Delirium	Drug: Melatonin Other: No intervention Drug: Midazolam	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group Patients in this group received nothing for sedation.	Other: No intervention No intervention was used.
Active Comparator: Midazolam group 7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.	Drug: Midazolam 7.5 mg of Midazolam orally.
Experimental: Melatonin group 5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively	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 Names: Midazolam

Arm

Intervention/Treatment

Placebo Comparator: Control Group

Patients in this group received nothing for sedation.

Other: No intervention

No intervention was used.

Active Comparator: Midazolam group

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

Drug: Midazolam

7.5 mg of Midazolam orally.

Experimental: Melatonin group

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

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 Names:

Midazolam

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1- Patients in good general health. 2. Baseline MDAS <13. 3. 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).