Plain English Summary
Background and study aims
Large studies show that the drug dexmedetomidine can provide sedation without reducing respiration (breathing) and affecting consciousness , but some studies have reported that dexmedetomidine reduces cerebral (brain) blood flow, partly due to constriction of blood vessels. Cerebral metabolic rate (rate of energy expenditure) also decreased. However, there is very little information about the effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate in traumatic brain injury patients. Therefore, the aim of this study is to gather information on the effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate in non-traumatic brain injury patients and traumatic brain injury patients separately.
Who can participate?
Non-traumatic brain injury patients and traumatic brain injury patients
What does the study involve?
Participants are randomly allocated to be treated with either dexmedetomidine or dexmedetomidine combined with dopamine. Ultrasound is used to measure cerebral blood flow, and blood samples are to measure cerebral metabolic rate before and after dexmedetomidine treatment.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Shanghai Sixth People's Hospital (China)
When is the study starting and how long is it expected to run for?
September 2011 to November 2011
Who is funding the study?
Shanghai Sixth People's Hospital (China)
Who is the main contact?
Miss Junhui Ji
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate
Acronym
Study hypothesis
The objective of this study is to observe the effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate in non-traumatic brain injury patients and traumatic brain injury patients.
Ethics approval
Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University, 14/09/2011, ref: 2011-50
Study design
Randomised prospective case-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Traumatic brain injury (TBI), cerebral blood flow (CBF) and cerebral metabolic rate (CMR)
Intervention
The German Philips Intellivue MP20 multi-function monitor is used for continuous monitoring of SBP, DBP, MAP, HR, RR and SpO2, and color Doppler ultrasound (esaote MyLab40, Italy, frequency 7.5 ~ 10MHZ) is used to measure carotid artery and vertebral artery blood flow at presedation, 70 minutes of administration of dexmedetomidine and 4 hours after discontinuing dexmedetomidine, cerebral blood flow will be obtained by the conversion formula. Dexmedetomidine is injected by a Braun 8714827 micro-pump for a loading dose of 1mg/kg (infusion 10 min), then a maintenance dose of 0.4mg.kg-1.h-1 (infusion 2h). In the dexmedetomidine group, dopamine is pumped to maintain blood pressure at normal low levels once the SBP is less than 90 mmHg or DBP is less than 50mmHg, and in the dexmedetomidine combined with dopamine group and traumatic brain injury patients group, dopamine is pumped to maintain blood pressure at the level before dexmedetomidine administration. After discontinuing infusing dexmedetomidine, dopamine can be gradually tapered to discontinue. Jugular vein and femoral arterial blood are analyzed by German GEM 3000 blood gas analyzer to measure cerebral metabolic rate by formula. Follow-up monitoring SBP, DBP, MAP, HR, RR and SpO2 of patients after discontinued infusing dexmedetomidine for 1 day.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dexmedetomidine
Primary outcome measure
Cerebral blood flow
Secondary outcome measures
1. Cerebral metabolic rate of oxygen
2. The dosage of dopamine
3. Diastolic blood pressure
4. Systolic blood pressure
5. Mean arterial pressure
6. Heart rate
7. Respiratory rate
8. Oxygen saturation
9. PaCO2
Overall trial start date
20/09/2011
Overall trial end date
20/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Electrocardiogram (ECG) examination was normal, no hypotension, no bradycardia, etc
2. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Brain tumor, hypertensive cerebral hemorrhage and non-traumatic brain injury patients
2. Patients combined heart failure, liver dysfunction, renal insufficiency, cardiac arrhythmias
3. Patients combined severe primary liver disease, severe primary renal disease, severe primary hematopoietic system diseases or mental illness
4. Pregnancy or breastfeeding women
5. Patients with allergies
6. Patients participating in other clinical trials
Recruitment start date
20/09/2011
Recruitment end date
20/11/2011
Locations
Countries of recruitment
China
Trial participating centre
Shanghai Sixth People's Hospital
Shanghai
200233
China
Sponsor information
Organisation
Shanghai Sixth People's Hospital (China)
Sponsor details
c/o Dr Xuemin Wang
Department of Anaesthesiology and ICU
Shanghai Sixth People's Hospital
600 Yi-Shan Road
Shanghai
200233
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Shanghai Sixth People's Hospital (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24102571
Publication citations
-
Results
Wang X, Ji J, Fen L, Wang A, Effects of dexmedetomidine on cerebral blood flow in critically ill patients with or without traumatic brain injury: a prospective controlled trial., Brain Inj, 2013, 27, 13-14, 1617-1622, doi: 10.3109/02699052.2013.831130.