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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408524
• Other study ID #: 594/2552(EC4)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2011
• Last updated: March 31, 2014
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The study was randomized equivalence trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Craniotomy
• Hypertension

Intervention

Drug:
• Diltiazem
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
• Labetalol
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of the patients who have systolic blood pressure below 140 mmHg		3 hours	Yes
Secondary	mean doses of the study drugs		3hr	Yes
Secondary	the number of patients with Adverse Events as a Measure of Safety and Tolerability		6 hour	Yes