Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/06/2011
Date assigned
10/10/2011
Last edited
02/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Miss Junhui Ji

ORCID ID

Contact details

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

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 September 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 below to request a patient information sheet

Condition

Traumatic brain injury (TBI), cerebral blood flow (CBF) and cerebral metabolic rate (CMR)

Intervention

We will use the German Philips Intellivue MP20 multi-function monitor for continuous monitoring SBP, DBP, MAP, HR, RR and SpO2, and use color Doppler ultrasound (esaote MyLab40, Italy, frequency 7.5 ~ 10MHZ) 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 10min), then a maintenance dose of 0.4mg.kg-1.h-1 (infusion 2h). In 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 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 measures

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

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 breast-feeding 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

Department of Anaesthesiology and ICU
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

http://www.6thhosp.com/index.asp

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24102571

Publication citations

  1. 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.

Additional files

Editorial Notes