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Trial Detail

CUHK_CCRB00562

2017-09-05

Prospective

CREC ref. no. 2017.303

Department of Anaesthesia and Intensive Care, CUHK

CUHK

N/A

Not Applicable

Andrew Tse

General office,
4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

3505 2735

andrewhwtse@link.cuhk.edu.hk

Department of Anaesthesia and Intensive Care, CUHK

Hong Kong

Andrew Tse

General office,
4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

3505 2735

andrewhwtse@link.cuhk.edu.hk

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Hong Kong

External validation of pharmacokinetic models of prolonged infusion of dexmedetomidine in adult critically ill patients

Pharmacokinetic models of prolonged infusion of dexmedetomidine in critically ill patients

在成年危重病人中使用延長輸注右美托咪定注射液的藥代動力學模型的外部驗證

Pharmacokinetic models of prolonged infusion of dexmedetomidine in critically ill patients

Hong Kong

Yes

2017-07-31

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.303

Critical illness

Drug

Dexmedetomidine

Intravenous

0.1-0.7 mcg/kg/hr

Upto 2 weeks

Continuous infusion

N/A

N/A

N/A

N/A

N/A

All patients admitted to the Prince of Wales Hospital in Hong Kong expecting to requiring prolonged sedation for more than 24 hours but less than 2 weeks of dexmedetomidine for mechanical ventilation will be included.

The exclusion criteria will include the following: history of intolerance to dexmedetomidine, use of centrally acting α2-agonsits or antagonists (eg. clonidine), need for continuous muscle relaxation, uncompensated circulatory failure (mean arterial pressure < 55mm Hg despite vasopressors and inotropes), severe bradycardia (heart rate < 50 beats/min), second or third degree atrioventricular block, severe hepatic impairment (bilirubin > 101 μmol/L), acute severe intracranial or spinal neurologic disorder, significant haematological, endocrine, metabolic or gastrointestinal disease, or burn injuries and other injuries requiring regular anaesthesia or surgery.

18

99

Both Male and Female

Observational

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

Not applicable

2017-09-07

23

Recruiting

Dexmedetomidine serum concentrations

Blood sampling

At the start of infusion, 0, 2, 4, 7, 10, 15, 20, 30, 40 and 60 min, and then at 2, 3, 4, 6, 12, 18 and 24 hours. If the patient is still receiving the infusion, samples will be taken twice a day. At the end of dexmedetomidine infusion (time = 0 min), and again at 2, 4, 7, 10, 15, 20, 30, 40, 60 min

Sedation score

Richmond Agitation Sedation Scale (RASS) scores

At the start of the infusion (t = 0), 1, 2, 3, 4, 6, 12, 18, 24 h, then three time daily during infusion. After the end of dexmedetomidine infusion, RASS scores will be measured at 0, 1, 2, 3, 4, 6,12,18, 24 and 36 hours.

No

2018-09-20

ChiCTR-OOC-17012631

2017-09-05

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