Comparison of nitroglycerin infusion and labetalol in acute arterial hypertension controlling in intracerebral hemorrhage patients admitted to intensive care unit
Comparison of Nitroglycerin and Labetalol infusion in controlling arterial hypertension in patients with intracerebral hemorrhage in the intensive care unit
Design
The current study was conducted as interventional study with control group.
Settings and conduct
In this interventional study, 20 patients with intracerebral hemorrhage admmited to intensive care unit of Urmia Imam Khomeini Hospital were treated with Labetalol (intervention group) and 34 patients with Nitroglycerin serum (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with intracerebral hemorrhage; Arterial hypertension; Patients admitted to the intensive care unit.
Exclusion criteria: Patients with a history of cerebral neoplasm; having a history of cerebrovascular diseases; having a history of cardiovascular disease
Intervention groups
Intervention group: 20 mg of Labetalol (as bolus form) in primary dose as intravenously and each 20 minutes was given as a bolus dose of 20-80 mg.
Control group (routine treatment): Nitroglycerin was prescribed as continuous infusion with 5 µg primary dose per minute and up to 200 µg per minute to control blood pressure.
Main outcome variables
Systolic and diastolic blood pressures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171221037983N2
Registration date:2018-05-02, 1397/02/12
Registration timing:retrospective
Last update:2018-05-02, 1397/02/12
Update count:0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Mohammad Amin Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
valizademohammadamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Comparison of nitroglycerin infusion and labetalol in acute arterial hypertension controlling in intracerebral hemorrhage patients admitted to intensive care unit
Public title
The effect of Nitroglycerin and Labetalol on hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with intracerebral hemorrhage
Patients with arterial hypertension
Patients admitted to the intensive care unit
Exclusion criteria:
Patients with history of brain neoplasm
History of cerebrovascular diseases
History of cardiovascular diseases
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were unaware of which of the study groups were.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Every hour in the first 24 hours after intervention
Method of measurement
SAADAT ALBURZ B9 Monitoring device
Secondary outcomes
1
Description
Severity of disease
Timepoint
Before and after intervention
Method of measurement
GCS score
Intervention groups
1
Description
Intervention group: 20 mg of Labetalol (as bolus form) in primary dose as intravenously and each 20 minutes was given as a bolus dose of 20-80 mg.
Category
Treatment - Drugs
2
Description
Control group: Nitroglycerin was prescribed as continuous infusion with 5 µg primary dose per minute and up to 200 µg per minute to control blood pressure.