Skip to main content
OpenTrials
Completed

NCT Number: NCT05640934

Melatonin for Post Operative Delirium Prevention in Elderly Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium in Old Age

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Incidence of delirium occurrence

    Time frame: 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 outcomes

  1. Degree of Sedation

    Time frame: Perioperative.

    Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation

  2. Intensity of pain

    Time frame: 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.

  3. Mean arterial blood pressure

    Time frame: Perioperative

    mmHg

  4. Heart rate

    Time frame: Perioperative

    beats/minute

  5. Hypotension

    Time frame: Perioperative

    Number of patients with hypotension

  6. Hypoxia

    Time frame: Perioperative

    Number of patients with hypoxia

  7. Blood transfusion needs

    Time frame: Perioperative

    Number of patients needed blood transfusion

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.