Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem

NCT ID: NCT01408524

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-12-31

Brief Summary

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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

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The study was randomized equivalence trial

Conditions

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Hypertension Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diltiazem

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Group Type ACTIVE_COMPARATOR

Diltiazem

Intervention Type DRUG

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Labetalol

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Group Type ACTIVE_COMPARATOR

Labetalol

Intervention Type DRUG

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Interventions

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Diltiazem

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Intervention Type DRUG

Labetalol

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Intervention Type DRUG

Other Intervention Names

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Herbessor Avexa

Eligibility Criteria

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Inclusion Criteria

* patients who scheduled for craniotomy for tomor removal

Exclusion Criteria

* allergic to labetalol or diltiazem
* Bradycardia \< 60 beat/min
* Second or third degree heart block
* Severe asthma or severe COPD
* Brain stem tumor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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busara sirivanasandha

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Busara - Sirivanasandha, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand

Other Identifiers

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594/2552(EC4)

Identifier Type: -

Identifier Source: org_study_id

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