Melatonin for Post Operative Delirium Prevention in Elderly Patients

Menoufia University

Status and phase: Completed; Phase 2

Conditions: Delirium in Old Age

Treatments: Drug: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05640934

11/2022 ANEST10

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Melatonin group

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo