Melatonin for Post Operative Delirium Prevention in Elderly Patients

NCT05640934 | Completed Phase 2

• 1 other identifier: 11/2022 ANEST10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Degree of Sedation

  Perioperative.

• Intensity of pain

  Perioperative

• Mean arterial blood pressure

  Perioperative

• Heart rate

  Perioperative

• Hypotension

  Perioperative

Study Arms (2)

Melatonin group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Melatonin DRUG

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.

Melatonin group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists (ASA) I to III physical status
• Elective colorectal procedures

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Abd-Elazeem A Elbakry, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

• Hazem E Elsersy, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

• Islam M El-Desoky, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: December 10, 2022
• Primary Completion: July 2, 2023
• Study Completion: July 5, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)