NCT01041066

Brief Summary

The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
Last Updated

December 31, 2009

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

December 30, 2009

Last Update Submit

December 30, 2009

Conditions

Patients Who Are Intubated for General AnesthesiaEndotracheal Intubation

Keywords

patients who are intubated for general anesthesia

Outcome Measures

Primary Outcomes (1)

  • hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)

    preinduction- 10 min after intubation

Study Arms (2)

group L

ACTIVE COMPARATOR

0.4 mg/kg labetalol

Drug: labetalol

group N

ACTIVE COMPARATOR

20 ㎍/kg nicardipine

Drug: nicardipine

Interventions

labetalolDRUG

0.4 mg/kg labetalol intravenously 4 min before intubation

group L
nicardipineDRUG

20 ㎍/kg nicardipine intravenously 4 min before intubation

group N

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for general anesthesia with endotracheal intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22364823DERIVED

MeSH Terms

Interventions

LabetalolNicardipine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jung-Hee Ryu, Ph.D

CONTACT

82-31-787-7497jinaryu@lycos.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Last Updated

December 31, 2009

Record last verified: 2009-09

Locations

KR(1)