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

Mahidol University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertension; Craniotomy

Treatments: Drug: Diltiazem; Drug: Labetalol

Study type: Interventional

Funder types: Other

Identifiers

NCT01408524

594/2552(EC4)

Details and patient eligibility

About

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.

Full description

The study was randomized equivalence trial

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups

Diltiazem

Active Comparator group

Description:

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

Treatment:

Drug: Diltiazem

Labetalol

Active Comparator group

Description:

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

Treatment:

Drug: Labetalol