Melatonin for Post Operative Delirium Prevention in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-10

Study Completion Date

2023-07-05

Brief Summary

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The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.

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Detailed Description

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This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.

Conditions

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Delirium in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin group

The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.

Control group

The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.

Interventions

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Melatonin

The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.

Intervention Type DRUG

Placebo

The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anaesthesiologists (ASA) I to III physical status
* Elective colorectal procedures

Exclusion Criteria

* Allergy to the research drugs,
* Patients who have vision or hearing impairment
* History of cerebral disorders
* Uncorrected acid-base, fluid, and electrolyte abnormalities
* History of central nervous system function affecting drugs.
* Chronic sedative-hypnotic administration at least one month prior to surgery
* Alcohol abuse
* Patients with recorded preoperative nursing delirium screening score ≥ 2.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No