HypertensionPhase 1/2NCT01408524
Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem
A Phase 1/2 study testing Diltiazem and Labetalol in people with Hypertension and Craniotomy, run by Mahidol University.
Trial summary
The purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Craniotomy
- What is being tested?
- Diltiazem and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Dec 2013
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who scheduled for craniotomy for tomor removal
Who cannot join
- allergic to labetalol or diltiazem
- Bradycardia < 60 beat/min
- Second or third degree heart block
- Severe asthma or severe COPD
- Brain stem tumor
About this study
Official title: A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem
The purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor).
Also the investigators seek to determine the effective dose of the antihypertensive drugs and their side effects in Thai population.
Read the detailed description
The study was randomized equivalence trial
- Conditions
- Hypertension, Craniotomy
- Being tested
- Diltiazem, Labetalol
- Keywords
- Hypertension, emergence, craniotomy, Hypertension during the emergence after craniotomy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiltiazemDrug
Also called Herbessor
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
LabetalolDrug
Also called Avexa
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem | Active comparator | 2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence Receives: Drug: Diltiazem |
| Labetalol | Active comparator | 2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of the patients who have systolic blood pressure below 140 mmHg
Measured: 3 hours
Secondary outcomes (2)
mean doses of the study drugs
Measured: 3hr
the number of patients with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, busara sirivanasandha, Mahidol University
- Investigators
- Busara - Sirivanasandha, MD, Principal investigator, Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408524
- Sponsor's protocol ID
- 594/2552(EC4)
- Status last verified
- Mar 2014
- First submitted
- 11 Jul 2011
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem
- ClinicalTrials.gov ID
- NCT01408524
- Acronym / sponsor ID
- 594/2552(EC4)
- Conditions
- Hypertension, Craniotomy
- Keywords
- Hypertension, emergence, craniotomy, Hypertension during the emergence after craniotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Aug 2011 (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 purpose of this study is to determine the effectiveness of the antihypertensive drugs in the control of emergence blood pressure after tumor resection craniotomy; compared between labetalol (Avexa) and diltiazem (Herbessor).
Also the investigators seek to determine the effective dose of the antihypertensive drugs and their side effects in Thai population.
Detailed description
The study was randomized equivalence trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diltiazem | Active comparator | Drug: Diltiazem2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence |
| Labetalol | Active comparator | Drug: Labetalol2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who scheduled for craniotomy for tomor removal
Key exclusion criteria (5 listed)
- allergic to labetalol or diltiazem
- Bradycardia < 60 beat/min
- Second or third degree heart block
- Severe asthma or severe COPD
- Brain stem tumor
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 |
|---|---|---|
| DiltiazemAlso: Herbessor2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence | Drug | Diltiazem |
| LabetalolAlso: Avexa2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence | Drug | Labetalol |
Primary outcome
The number of the patients who have systolic blood pressure below 140 mmHg
Time frame: 3 hours
2 secondary outcomes
mean doses of the study drugs
Time frame: 3hr
the number of patients with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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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.
Busara - Sirivanasandha, MD principal investigator
Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Diltiazem and Labetalol in people with Hypertension and Craniotomy, run by Mahidol University.
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 5 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: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of the patients who have systolic blood pressure below 140 mmHg (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2014.