Nicardipine Versus Labetalol During Intubation | NCT01041066

Studies
Nicardipine Versus Labetalol During Intubation

NCT01041066

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2009Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Patients Who Are Intubated for General Anesthesia
Endotracheal Intubation

Interventions

labetalol
nicardipine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Not provided

First Submitted Date

Dec 30, 2009

First Submission Date that Met QC Criteria

Dec 30, 2009

First Posted Date

Dec 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2009

Last Update Posted Date

Dec 31, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group L	Active Comparator	0.4 mg/kg labetalol	Drug: labetalol
group N	Active Comparator	20 ㎍/kg nicardipine	Drug: nicardipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
labetalol	Drug	0.4 mg/kg labetalol intravenously 4 min before intubation	group L

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)		preinduction- 10 min after intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Hee Ryu, Ph.D	Contact	82-31-787-7497		jinaryu@lycos.co.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22364823	Derived	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.

Type	Date	Date Unknown
Release	Sep 7, 2010
Reset	Sep 27, 2010

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals