- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041066
Nicardipine Versus Labetalol During Intubation
December 30, 2009 updated by: Seoul National University Bundang Hospital
The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jung-Hee Ryu, Ph.D
- Phone Number: 82-31-787-7497
- Email: jinaryu@lycos.co.kr
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Jung-Hee Ryu, Ph.D
- Phone Number: 82-31-787-7497
- Email: jinaryu@lycos.co.kr
-
-
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 to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for general anesthesia with endotracheal intubation
Exclusion Criteria:
- Patients with heart failure or coronary artery disease 2-3 degree atrio-ventricular block or severe bradycardia (< 45 beats/min) asthma, bronchial spasm or chronic obstructive pulmonary disease patients with anticipated difficult intubation (Mallampati class III, IV) severe hepatic or renal dysfunction allergy or contraindication to study medication
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group L
0.4 mg/kg labetalol
|
0.4 mg/kg labetalol intravenously 4 min before intubation
|
Active Comparator: group N
20 ㎍/kg nicardipine
|
20 ㎍/kg nicardipine intravenously 4 min before intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)
Time Frame: preinduction- 10 min after intubation
|
preinduction- 10 min after intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
December 30, 2009
First Submitted That Met QC Criteria
December 30, 2009
First Posted (Estimate)
December 31, 2009
Study Record Updates
Last Update Posted (Estimate)
December 31, 2009
Last Update Submitted That Met QC Criteria
December 30, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- 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
- Nicardipine
Other Study ID Numbers
- nicardipine-labetalol
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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