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Melatonin for Post Operative Delirium Prevention in Elderly Patients

Primary Purpose

Delirium in Old Age

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium in Old Age

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Melatonin group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Degree of Sedation
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation
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.
Mean arterial blood pressure
mmHg
Heart rate
beats/minute
Hypotension
Number of patients with hypotension
Hypoxia
Number of patients with hypoxia
Blood transfusion needs
Number of patients needed blood transfusion

Full Information

First Posted
November 29, 2022
Last Updated
July 14, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05640934
Brief Title
Melatonin for Post Operative Delirium Prevention in Elderly Patients
Official Title
The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2022 (Actual)
Primary Completion Date
July 2, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
Primary Outcome Measure Information:
Title
Incidence of delirium occurrence
Description
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.
Time Frame
Perioperative.
Secondary Outcome Measure Information:
Title
Degree of Sedation
Description
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation
Time Frame
Perioperative.
Title
Intensity of pain
Description
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.
Time Frame
Perioperative
Title
Mean arterial blood pressure
Description
mmHg
Time Frame
Perioperative
Title
Heart rate
Description
beats/minute
Time Frame
Perioperative
Title
Hypotension
Description
Number of patients with hypotension
Time Frame
Perioperative
Title
Hypoxia
Description
Number of patients with hypoxia
Time Frame
Perioperative
Title
Blood transfusion needs
Description
Number of patients needed blood transfusion
Time Frame
Perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abd-Elazeem A Elbakry, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hazem E Elsersy, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Islam M El-Desoky, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
State/Province
Shebin El-kom
ZIP/Postal Code
32511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Melatonin for Post Operative Delirium Prevention in Elderly Patients

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