- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01408524
Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem
March 31, 2014 updated by: busara sirivanasandha, Mahidol University
A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem
The purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor).
Also the investigators seek to determine the effective dose of the antihypertensive drugs and their side effects in Thai population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was randomized equivalence trial
Study Type
Interventional
Enrollment (Actual)
184
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who scheduled for craniotomy for tomor removal
Exclusion Criteria:
- allergic to labetalol or diltiazem
- Bradycardia < 60 beat/min
- Second or third degree heart block
- Severe asthma or severe COPD
- Brain stem tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diltiazem
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
|
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Names:
|
Active Comparator: Labetalol
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
|
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of the patients who have systolic blood pressure below 140 mmHg
Time Frame: 3 hours
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean doses of the study drugs
Time Frame: 3hr
|
3hr
|
the number of patients with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 hour
|
6 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Busara - Sirivanasandha, MD, Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
August 2, 2011
First Posted (Estimate)
August 3, 2011
Study Record Updates
Last Update Posted (Estimate)
April 1, 2014
Last Update Submitted That Met QC Criteria
March 31, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sympathomimetics
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Labetalol
- Diltiazem
Other Study ID Numbers
- 594/2552(EC4)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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