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

Phase 1

Completed

• Conditions: Hypertension; Craniotomy
• Interventions: Drug: Labetalol; Drug: Diltiazem

• Registration Number: NCT01408524
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-11
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Labetalol	Labetalol	2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Diltiazem	Diltiazem	2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Primary Outcome Measures

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

Secondary Outcome Measures

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