Melatonin for Post Operative Delirium Prevention in Elderly Patients

The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Delirium in Old Age
• Intervention / Treatment: Drug: Melatonin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Abd-Elazeem A Elbakry, MD; Phone Number: 002-010-21678889; Email: abdelazeem.abd@med.menofia.edu.eg
• Study Contact Backup: Name: Hazem E Elsersy, MD; Phone Number: 002-010-91096655; Email: hazelsersy@hotmail.com

Study Locations

• Egypt
  • Shebin El-kom
    • Cairo, Shebin El-kom, Egypt, 32511
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Placebo Comparator: Control group; The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.	Drug: Placebo; The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Perioperative.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Abd-Elazeem A Elbakry, MD, Menoufia University; Principal Investigator: Hazem E Elsersy, MD, Menoufia University; Principal Investigator: Islam M El-Desoky, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): July 2, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 11/2022 ANEST10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No