Melatonin for Post Operative Delirium Prevention in Elderly Patients

Phase 2

Completed

• Conditions: Delirium in Old Age
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT05640934
• Lead Sponsor: Menoufia University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2022-12-10
• Status Verified: 2023-07
• Primary Completion: 2023-07-02
• Study Completion: 2023-07-05
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
Melatonin group	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.

Primary Outcome Measures

Name	Time	Method
Incidence of delirium occurrence	Perioperative.	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.

Secondary Outcome Measures

Name	Time	Method
Blood transfusion needs	Perioperative	Number of patients needed blood transfusion
Degree of Sedation	Perioperative.	Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation
Intensity of pain	Perioperative	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.
Mean arterial blood pressure	Perioperative	mmHg
Heart rate	Perioperative	beats/minute
Hypotension	Perioperative	Number of patients with hypotension
Hypoxia	Perioperative	Number of patients with hypoxia

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Cairo, Shebin El-kom, Egypt