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Completed

NCT Number: NCT01408524

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Craniotomy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

The study was randomized equivalence trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diltiazem

Drug

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

Other names: Herbessor

labetalol

Drug

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

Other names: Avexa

Primary outcomes

  1. The number of the patients who have systolic blood pressure below 140 mmHg

    Time frame: 3 hours

Secondary outcomes

  1. mean doses of the study drugs

    Time frame: 3hr

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

    Time frame: 6 hour

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 3, 2011
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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