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

Condition(s) targeted: Hypertension; Craniotomy

Intervention: Diltiazem (Drug); Labetalol (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Busara - Sirivanasandha, MD, Principal Investigator, Affiliation: Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

mean doses of the study drugs

the number of patients with Adverse Events as a Measure of Safety and Tolerability

Detailed description: The study was randomized equivalence trial

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: February 2010
Last updated: March 31, 2014