Melatonin for Post Operative Delirium Prevention in Elderly Patients

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640934
• Other study ID #: 11/2022 ANEST10
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: July 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 5, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Mean arterial blood pressure	mmHg	Perioperative
Secondary	Heart rate	beats/minute	Perioperative
Secondary	Hypotension	Number of patients with hypotension	Perioperative
Secondary	Hypoxia	Number of patients with hypoxia	Perioperative
Secondary	Blood transfusion needs	Number of patients needed blood transfusion	Perioperative