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

Mahidol University184 enrolled

Overview

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.

The study was randomized equivalence trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

184

Conditions

Hypertension Craniotomy

Interventions

DiltiazemDRUG

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

LabetalolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The number of the patients who have systolic blood pressure below 140 mmHg

Time frame: 3 hours

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

Data from ClinicalTrials.gov

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