Neuroprotective Effect of Dexomitomidine
NCT05487742 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-08-04
Summary
patient wih mild to moderate traumatic brain injury in ICU will be randomisly distributed into two groups Group I (control group): Patients of this group receive placebo infusion for 72 hours. Group II (DEX group): Patients of this group receive 0.5 ug/kg/hr dexmedetomidine continuous infusion for 72 hour Patient demographics, including age, sex, weight, primary diagnosis, Acute Physiology and Chronic Health Evaluation (APACHE) II score and postresuscitation Glasgow Coma Scale (GCS) score will be collected. CBF will be measured at pre-sedation and after cessation of sedation (dexmedetomidine administration). The CMRe and CMRe/CBF will also be calculated. Measurements of blood gas analysis and haemodynamic parameters \[systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and heart rate (HR)\] will be collected at pre-sedation and after cessation of sedation (dexmedetomidine administration).
Conditions
- Dexmedetomidine Neuroprotective Effect in Traumatic Brain Injury
Interventions
- DRUG
-
Dexmedetomidine
dexmedetomidine will be infused for 72 hour in mild and moderate traumatic brain injury patient
- DRUG
-
placebo salin infusion
salin infused as aplacebo for 72 hours
Sponsors & Collaborators
-
Tanta University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-04
- Primary Completion
- 2022-12-31
- Completion
- 2023-01-31
Countries
- Egypt
Study Locations
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