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

March 31, 2014 updated by: busara sirivanasandha, Mahidol University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The study was randomized equivalence trial

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diltiazem
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Names:
  • Herbessor
Active Comparator: Labetalol
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Names:
  • Avexa

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Busara - Sirivanasandha, MD, Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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