Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Tanta University90 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Dexmedetomidine Melatonin Delirium

Interventions

DexmedetomidineDRUG

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.

Melatonin 3 MGDRUG

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

SalineDRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 14 days from admission to intensive care unit

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Central Contacts

Eslam Eslam, MD

CONTACT

01004415074 salemeslam913@gmail.com

Data from ClinicalTrials.gov

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