Patients Who Are Intubated for General AnesthesiaNCT01041066
Nicardipine Versus Labetalol During Intubation
A study testing labetalol and nicardipine in people with Patients Who Are Intubated for General Anesthesia and Endotracheal Intubation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Patients Who Are Intubated for General Anesthesia, Endotracheal Intubation
- What is being tested?
- labetalol and nicardipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general anesthesia with endotracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jung-Hee Ryu, Ph.D, 82-31-787-7497, jinaryu@lycos.co.kr
About this study
The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.
- Being tested
- labetalol, nicardipine
- Keywords
- patients who are intubated for general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labetalolDrug
0.4 mg/kg labetalol intravenously 4 min before intubation
nicardipineDrug
20 ㎍/kg nicardipine intravenously 4 min before intubation
| Study group | Role | What they receive |
|---|---|---|
| group L | Active comparator | 0.4 mg/kg labetalol Receives: Drug: labetalol |
| group N | Active comparator | 20 ㎍/kg nicardipine Receives: Drug: nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)
Measured: preinduction- 10 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Who Are Intubated for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041066
- Sponsor's protocol ID
- nicardipine-labetalol
- Status last verified
- Sep 2009
- First submitted
- 30 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
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.
PubMed 22364823
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicardipine Versus Labetalol During Intubation
- ClinicalTrials.gov ID
- NCT01041066
- Acronym / sponsor ID
- nicardipine-labetalol
- Keywords
- patients who are intubated for general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (estimated)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group L | Active comparator | Drug: labetalol0.4 mg/kg labetalol |
| group N | Active comparator | Drug: nicardipine20 ㎍/kg nicardipine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for general anesthesia with endotracheal intubation
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| labetalol0.4 mg/kg labetalol intravenously 4 min before intubation | Drug | group L |
| nicardipine20 ㎍/kg nicardipine intravenously 4 min before intubation | Drug | group N |
Primary outcome
hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)
Time frame: preinduction- 10 min after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
- Derived from this study: PubMed 22364823Ryu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing labetalol and nicardipine in people with Patients Who Are Intubated for General Anesthesia and Endotracheal Intubation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Hee Ryu, Ph.D (82-31-787-7497, jinaryu@lycos.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate) (time frame: preinduction- 10 min after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2009.