Back to resultsThe Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Primary Purpose
Delirium, Anesthesia Emergence, Delirium
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Melatonin
No intervention
Midazolam
Sponsored by
About this trial
This is an interventional prevention trial for Delirium, Anesthesia Emergence focused on measuring Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively
Eligibility Criteria
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).
Sites / Locations
- Al-Kadhemya Private Hospital
- Ghazi Al-Hariri Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Control Group
Midazolam group
Melatonin group
Arm Description
Patients in this group received nothing for sedation.
7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.
5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05236907
First Posted
January 6, 2022
Last Updated
February 2, 2022
Sponsor
University of Baghdad
1. Study Identification
Unique Protocol Identification Number
NCT05236907
Brief Title
The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Official Title
The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Anesthesia Emergence, Delirium
Keywords
Delirium, melatonin, patients, surgery, postoperative, benzodiazepines, orthopedic, preoperatively
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
It has been done on all the study's contributors and workers.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients in this group received nothing for sedation.
Arm Title
Midazolam group
Arm Type
Active Comparator
Arm Description
7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.
Arm Title
Melatonin group
Arm Type
Experimental
Arm Description
5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively
Intervention Type
Drug
Intervention Name(s)
Melatonin
Other Intervention Name(s)
Midazolam
Intervention Description
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
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention was used.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
7.5 mg of Midazolam orally.
Primary Outcome Measure Information:
Title
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
Description
This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Al-Kadhemya Private Hospital
City
Baghdad
ZIP/Postal Code
10047
Country
Iraq
Facility Name
Ghazi Al-Hariri Teaching Hospital
City
Baghdad
ZIP/Postal Code
10047
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
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