We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicardipine Versus Labetalol During Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01041066
Recruitment Status : Unknown
Verified September 2009 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2009
Last Update Posted : December 31, 2009
Sponsor:
Information provided by:
Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2009
First Posted Date  ICMJE December 31, 2009
Last Update Posted Date December 31, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2009)		 hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate) [ Time Frame: preinduction- 10 min after intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicardipine Versus Labetalol During Intubation
Official Title  ICMJE Not Provided
Brief Summary The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Patients Who Are Intubated for General Anesthesia
  • Endotracheal Intubation
Intervention  ICMJE
  • Drug: labetalol
    0.4 mg/kg labetalol intravenously 4 min before intubation
  • Drug: nicardipine
    20 ㎍/kg nicardipine intravenously 4 min before intubation
Study Arms  ICMJE
  • Active Comparator: group L
    0.4 mg/kg labetalol
    Intervention: Drug: labetalol
  • Active Comparator: group N
    20 ㎍/kg nicardipine
    Intervention: Drug: nicardipine
Publications * Ryu JH, Apfel CC, Whelan R, Jeon YT, Hwang JW, Do SH, Ro YJ, Kim CS. Comparative prophylactic and therapeutic effects of intravenous labetalol 0.4 mg/kg and nicardipine 20 mug/kg on hypertensive responses to endotracheal intubation in patients undergoing elective surgeries with general anesthesia: a prospective, randomized, double-blind study. Clin Ther. 2012 Mar;34(3):593-604. doi: 10.1016/j.clinthera.2012.01.017. Epub 2012 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 30, 2009)		 70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01041066
Other Study ID Numbers  ICMJE nicardipine-labetalol
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Seoul National University Bundang Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seoul National University Bundang Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP