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
1
2
4.7
21.4

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. Mean arterial blood pressure [Perioperative]

    mmHg

  4. Heart rate [Perioperative]

    beats/minute

  5. Hypotension [Perioperative]

    Number of patients with hypotension

  6. Hypoxia [Perioperative]

    Number of patients with hypoxia

  7. 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:
No
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:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022