Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Delirium; Dexmedetomidine; Melatonin
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Melatonin 3 MG; Drug: Saline

Detailed Description

Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eslam Eslam, MD; Phone Number: 01004415074; Email: salemeslam913@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Eslam M Salem, Msc; Phone Number: 00201004415074; Email: salemeslam913@gmail.com
      • Sub-Investigator: Ayman A Youssef, MD
      • Sub-Investigator: Ghada F El-baradey, MD
      • Sub-Investigator: Shaimaa F Abdelkader, MD
      • Sub-Investigator: Alaa M Abo Hagar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D (n=30); 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; 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.; Other Names: DEX group
Experimental: Group M (n=30); patients will receive oral melatonin tablet 3 mg at 9:00 p.m.	Drug: Melatonin 3 MG; Patients will receive oral melatonin tablet 3 mg 9:00 p.m.; Other Names: N-acetyl-5-methoxytryptamine
Placebo Comparator: Control group; patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.	Drug: Saline; Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.	Delirium was assessed using Confusion Assessment Method for intensive care unit (CAM- ICU) score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.	14 days from admission to intensive care unit
Duration of delirium	Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU) score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.	14 days from admission to intensive care unit
Frequency of delirium	Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU)score at admission to ICU and every 12hr throughout the study. The final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.	14 days from admission to intensive care unit
Total dose of Haloperidol per day	Total dose of Haloperidol per day 14 days from admission to intensive care unit	14 days from admission to intensive care unit

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Antioxidants; Dexmedetomidine; Melatonin
• Other Study ID Numbers: Dexmedetomidine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No