In Thailand,
Conditions
Interventions
(5-
X-
X) A bolus dose of IV labetalol 5 mg will be initiated. Then a bolus dose of IV labetalol 5 mg can be given after 15 minutes if the subsequent SBP is >=140 mmHg. Then two more bolus doses of IV labeta
20) can be given,
every 15 minutes judged by attending physician(s) if the SBP is still >=140 mmHg.,(10-
X) A bolus dose of IV labetalol 10 mg will be initiated. Then a bolus dose of IV labetalol 10 mg can be given after 15 minutes if the subsequent SBP is >=140 mmHg. Then two more bolus doses of IV lab
20) can be given every 15 minutes judged by attending physician(s) if the SBP is still >=140 mmHg.
Active Comparator Drug,Active Comparator Drug
Labetalol 5 mg,Labetalol 10 mg
Sponsors
Great Eastern Drug Co., Ltd.
Great Eastern Drug Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years 2. Have diagnosis of spontaneous non-traumatic SAH or ICH confirmed by head computerized tomography 3. Have systolic blood pressure 180 mmHg 4. Need intravenous antihypertensive drug for blood pressure management 5. agree to consent
Exclusion criteria
Exclusion criteria: 1. Received any intravenous antihypertensive drug(s) before the enrollment 2. Current known pregnancy and parturition 3. Known hypersensitivity to labetalol or any ingredient in the formulation 4. Has one of these contraindications: 4.1 Obstructive airway disease (e.g., bronchial asthma, COPD) 4.2 Heart rate <=60 bpm 4.3 2nd and 3rd degree heart block 4.4 uncontrolled heart failure 4.5 metabolic acidosis 4.6 severe peripheral arterial disease 5. Inappropriate candidate considered by attending physician(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achievement at less than 140 mmHg after labetalol administration predose, 15, 30, 45, 60, 75,90,105, 120 min, ..., 24 h blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieving SBP less than 140 mmHg predose, 15, 30, 45, 60, 75,90,105, 120 min, ..., 24 h blood pressure ,Total dosage of achieving SBP less than 140 mmHg at the end of the study dose level,Adverse events such as bradycardia and hypotension at the end of the study symtom,Rescued medication for managing blood pressure at the end of the study drug name | — |
Countries
Thailand
Contacts
Public ContactPrajak Srirabheebhat
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed