Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium

October 16, 2023 updated by: eslam salem, Tanta University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Recruiting
        • Tanta University
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
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.
Time Frame: 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.
14 days from admission to intensive care unit
Duration of delirium
Time Frame: 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.
14 days from admission to intensive care unit
Frequency of delirium
Time Frame: 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.
14 days from admission to intensive care unit
Total dose of Haloperidol per day
Time Frame: 14 days from admission to intensive care unit
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

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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