Delirium Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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 |
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