Melatonin for Post Operative Delirium Prevention in Elderly Patients

Menoufia University100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Delirium in Old Age

Interventions

MelatoninDRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine

Cairo, Shebin El-kom, Egypt

Outcomes

Primary Outcomes

Incidence of delirium occurrence

Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium.

Time frame: Perioperative.

Secondary Outcomes

Degree of Sedation

Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation

Time frame: Perioperative.

Intensity of pain

Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain.

Time frame: Perioperative

Mean arterial blood pressure

mmHg

Time frame: Perioperative

Heart rate

beats/minute

Time frame: Perioperative

Hypotension

Number of patients with hypotension

Time frame: Perioperative

Hypoxia

Number of patients with hypoxia

Time frame: Perioperative

Blood transfusion needs

Number of patients needed blood transfusion

Time frame: Perioperative

Data from ClinicalTrials.gov

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