The effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate

ISRCTN ISRCTN57998533
DOI https://doi.org/10.1186/ISRCTN57998533
Secondary identifying numbers N/A
Submission date
28/06/2011
Registration date
10/10/2011
Last edited
16/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Miss Junhui Ji
Scientific

Department of Anaesthesiology and ICU
Shanghai Sixth People's Hospital
600 Yi-Shan Road
Shanghai
200233
China

Study information

Study designRandomised prospective case-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate
Study objectivesThe 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(s)Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University, 14/09/2011, ref: 2011-50
Health condition(s) or problem(s) studiedTraumatic brain injury (TBI), cerebral blood flow (CBF) and cerebral metabolic rate (CMR)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dexmedetomidine
Primary outcome measureCerebral blood flow
Secondary outcome measures1. 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 study start date20/09/2011
Completion date20/11/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. Electrocardiogram (ECG) examination was normal, no hypotension, no bradycardia, etc
2. Written informed consent
Key exclusion criteria1. 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
Date of first enrolment20/09/2011
Date of final enrolment20/11/2011

Locations

Countries of recruitment

  • China

Study participating centre

Shanghai Sixth People's Hospital
Shanghai
200233
China

Sponsor information

Shanghai Sixth People's Hospital (China)
Hospital/treatment centre

c/o Dr Xuemin Wang
Department of Anaesthesiology and ICU
Shanghai Sixth People's Hospital
600 Yi-Shan Road
Shanghai
200233
China

Website http://www.6thhosp.com/index.asp
ROR logo "ROR" https://ror.org/049zrh188

Funders

Funder type

Hospital/treatment centre

Shanghai Sixth People's Hospital (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2013 Yes No

Editorial Notes

16/06/2017: Plain English summary added.