Neuroprotective Effect of Dexomitomidine
Evaluation of Neuroprotective Effect of Dexmedetomidine in Traumatic Brain Injury
1 other identifier
interventional
80
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2022
CompletedFirst Submitted
Initial submission to the registry
August 2, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 4, 2022
August 1, 2022
6 months
August 2, 2022
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The change in CBF during sedation.
cerebral blood flow will be measured whether changed by dexmedetomine infusion or not
6 months
Study Arms (2)
Group I (control group):
PLACEBO COMPARATORPatients of this group receive placebo infusion for 72 hours.
Group II (DEX group):
ACTIVE COMPARATORPatients of this group receive 0.5 ug/kg/hr dexmedetomidine continuous infusion for 72 hour
Interventions
dexmedetomidine will be infused for 72 hour in mild and moderate traumatic brain injury patient
Eligibility Criteria
You may not qualify if:
- Patient relative refusal. 2-Severe traumatic brain injury GCS \< 8 3-prescence of other organ injury. 4-MAP lower than 80 mmHg 5- hepatic or kidney function dysfunction 6-received any vasoactive agents or sedatives or recieve drugs that affect CBF during the experiment 7- Pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Medicine Tanta University
Tanta, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- no participant ,investigator or outcome assessor in ICU know in which group patient is allocated
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
August 2, 2022
First Posted
August 4, 2022
Study Start
June 4, 2022
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
August 4, 2022
Record last verified: 2022-08