Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

NCT06076668 | Unknown

• 1 other identifier: Dexmedetomidine
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.

Conditions

Dexmedetomidine; Melatonin; Delirium

Outcome Measures

Primary Outcomes (1)

• The incidence of delirium

  The incidence of delirium within 14 days from admission to the intensive care unit (ICU) or until ICU discharge before this time. Every 12 hours throughout the study.

  14 days from admission to intensive care unit

Secondary Outcomes (4)

• The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.

  14 days from admission to intensive care unit

• Duration of delirium

  14 days from admission to intensive care unit

• Frequency of delirium

  14 days from admission to intensive care unit

• Total dose of Haloperidol per day

  14 days from admission to intensive care unit

Study Arms (3)

Group D (n=30)

EXPERIMENTAL

patients will receive intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.

Drug: Dexmedetomidine

Group M (n=30)

EXPERIMENTAL

patients will receive oral melatonin tablet 3 mg at 9:00 p.m.

Drug: Melatonin 3 MG

Control group

PLACEBO COMPARATOR

patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Patients will receive an intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.

Also known as: DEX group

Group D (n=30)

Melatonin 3 MG DRUG

Patients will receive oral melatonin tablet 3 mg 9:00 p.m.

Also known as: N-acetyl-5-methoxytryptamine

Group M (n=30)

Saline DRUG

Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 21 years or older.
• Either gender.
• Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).
• Richmond Agitation Sedation Scale (RASS) \>-1.
• No basic delirium or mood changes before admission to intensive care unit(ICU).

You may not qualify if:

• Patient refusal.
• History of irreversible brain disease consistent with severe dementia.
• Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).
• Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.
• Acute alcohol withdrawal requiring benzodiazepine administration.
• History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).
• The expected duration of intensive care unit (ICU) stay less than 5 days.
• Inability to obtain informed consent.
• Pregnancy.
• Allergy to dexmedetomidine or melatonin.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Melatonin; Sodium Chloride; Control Groups

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Eslam Eslam, MD

CONTACT

01004415074; salemeslam913@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 11, 2023
• Study Start: October 16, 2023
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)