The effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate
| ISRCTN | ISRCTN57998533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57998533 |
| Protocol serial number | N/A |
| Sponsor | Shanghai Sixth People's Hospital (China) |
| Funder | Shanghai Sixth People's Hospital (China) |
- 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
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
Scientific
Department of Anaesthesiology and ICU
Shanghai Sixth People's Hospital
600 Yi-Shan Road
Shanghai
200233
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised prospective case-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effects of dexmedetomidine on cerebral blood flow and cerebral metabolic rate |
| Study objectives | 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(s) | Ethics Committee of Shanghai Sixth People's Hospital, Shanghai Jiaotong University, 14/09/2011, ref: 2011-50 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Dexmedetomidine |
| Primary outcome measure(s) |
Cerebral blood flow |
| Key secondary outcome measure(s) |
1. Cerebral metabolic rate of oxygen |
| Completion date | 20/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Electrocardiogram (ECG) examination was normal, no hypotension, no bradycardia, etc 2. Written informed consent |
| Key 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 |
| Date of first enrolment | 20/09/2011 |
| Date of final enrolment | 20/11/2011 |
Locations
Countries of recruitment
- China
Study participating centre
200233
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/06/2017: Plain English summary added.
