Melatonin for Post Operative Delirium Prevention in Elderly Patients

Sponsor

Menoufia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05640934

Collaborator

(none)

100

Enrollment

Location

Arms

4.7

Anticipated Duration (Months)

21.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Delirium in Old Age	Drug: Melatonin Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 10, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Blood transfusion needs [Perioperative]
Number of patients needed blood transfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Cairo	Shebin El-kom	Egypt	32511

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abd-Elazeem Abd-Elhameed Elbakry, Assistant professor, Menoufia University

ClinicalTrials.gov Identifier:

NCT05640934

Other Study ID Numbers:

11/2022 ANEST10

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 13, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Melatonin

Study Results

No Results Posted as of Dec 13, 2022