Trials Sponsors Conditions Drugs Pricing

Conditions

Delirium Delirium, Anesthesia Emergence

Keywords

Deliriummelatoninpatientssurgerypostoperativebenzodiazepinesorthopedicpreoperatively

Outcome Measures

Primary Outcomes (1)

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.
1 week

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Patients in this group received nothing for sedation.

Other: No intervention

Midazolam group

ACTIVE COMPARATOR

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

Drug: Midazolam

Melatonin group

EXPERIMENTAL

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

Drug: Melatonin

Interventions

MelatoninDrug

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.

Also known as: Midazolam

Melatonin group

No interventionOther

Eligibility Criteria

Age60 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients in good general health. 2. Baseline MDAS \<13. 3. No seizure disorder.

You may not qualify if:

Sponsors & Collaborators

University of Baghdad
Otherlead

Study Sites (2)

Al-Kadhemya Private Hospital

Baghdad, 10047, Iraq

Ghazi Al-Hariri Teaching Hospital

Baghdad, 10047, Iraq

MeSH Terms

Conditions

Emergence DeliriumDelirium

Interventions

MelatoninMidazolam

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: It has been done on all the study's contributors and workers.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 11, 2022

Study Start

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Control Group

Midazolam group

Melatonin group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Control Group

Midazolam group

Melatonin group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations