Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076668
• Other study ID #: Dexmedetomidine
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: October 20, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: Eslam Eslam, MD
• Phone: 01004415074
• Email: salemeslam913[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine
• Melatonin

Intervention

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.
• Melatonin 3 MG
Patients will receive oral melatonin tablet 3 mg 9:00 p.m.
• Saline
Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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