Back to resultsDexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
Primary Purpose
Dexmedetomidine, Melatonin, Delirium
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Melatonin 3 MG
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Dexmedetomidine
Eligibility Criteria
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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group D (n=30)
Group M (n=30)
Control group
Arm Description
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.
patients will receive oral melatonin tablet 3 mg at 9:00 p.m.
patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Total dose of Haloperidol per day
Total dose of Haloperidol per day 14 days from admission to intensive care unit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06076668
Brief Title
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
Official Title
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
October 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Melatonin, Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group D (n=30)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group M (n=30)
Arm Type
Experimental
Arm Description
patients will receive oral melatonin tablet 3 mg at 9:00 p.m.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEX group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Melatonin 3 MG
Other Intervention Name(s)
N-acetyl-5-methoxytryptamine
Intervention Description
Patients will receive oral melatonin tablet 3 mg 9:00 p.m.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Control group
Intervention Description
Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.
Primary Outcome Measure Information:
Title
The incidence of delirium
Description
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 Outcome Measure Information:
Title
The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.
Description
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
Title
Duration of delirium
Description
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
Title
Frequency of delirium
Description
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
Title
Total dose of Haloperidol per day
Description
Total dose of Haloperidol per day 14 days from admission to intensive care unit
Time Frame
14 days from admission to intensive care unit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eslam Eslam, MD
Phone
01004415074
Email
salemeslam913@gmail.com
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eslam M Salem, Msc
Phone
00201004415074
Email
salemeslam913@gmail.com
First Name & Middle Initial & Last Name & Degree
Ayman A Youssef, MD
First Name & Middle Initial & Last Name & Degree
Ghada F El-baradey, MD
First Name & Middle Initial & Last Name & Degree
Shaimaa F Abdelkader, MD
First Name & Middle Initial & Last Name & Degree
Alaa M Abo Hagar, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
We'll reach out to this number within 24 hrs