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

A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408524

Enrollment

184

Registered

2011-08-03

Start date

2010-02-28

Completion date

2013-12-31

Last updated

2014-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy, Hypertension

Keywords

Hypertension, emergence, craniotomy, Hypertension during the emergence after craniotomy

Brief 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). 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

Interventions

DRUGDiltiazem

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

DRUGLabetalol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The number of the patients who have systolic blood pressure below 140 mmHg	3 hours

Secondary

Measure	Time frame
mean doses of the study drugs	3hr
the number of patients with Adverse Events as a Measure of Safety and Tolerability	6 hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026