Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Not Applicable

Recruiting

• Conditions: Dexmedetomidine; Melatonin; Delirium
• Interventions: Drug: Saline; Drug: Melatonin 3 MG; Drug: Dexmedetomidine

• Registration Number: NCT06076668
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-16
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-07
• Study First Posted: 2023-10-11
• Study Start: 2023-10-16
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.
Group M (n=30)	Melatonin 3 MG	patients will receive oral melatonin tablet 3 mg at 9:00 p.m.
Group D (n=30)	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
The incidence of delirium	14 days from admission to intensive care unit	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Frequency of delirium	14 days from admission to intensive care unit	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.
Total dose of Haloperidol per day	14 days from admission to intensive care unit	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	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt