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

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ClinicalTrials.gov Identifier: NCT01408524
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
busara sirivanasandha, 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.


Condition or disease Intervention/treatment Phase
Hypertension Craniotomy Drug: Diltiazem Drug: Labetalol Phase 1 Phase 2

Detailed Description:
The study was randomized equivalence trial

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Study in the Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol (Avexa) and Diltiazem
Study Start Date : February 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Diltiazem
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Drug: Diltiazem
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Name: Herbessor
Active Comparator: Labetalol
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Drug: Labetalol
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Other Name: Avexa



Primary Outcome Measures :
  1. The number of the patients who have systolic blood pressure below 140 mmHg [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408524


Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Busara - Sirivanasandha, MD Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand

Responsible Party: busara sirivanasandha, Miss, Mahidol University
ClinicalTrials.gov Identifier: NCT01408524     History of Changes
Other Study ID Numbers: 594/2552(EC4)
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by busara sirivanasandha, Mahidol University:
Hypertension
emergence
craniotomy
Hypertension during the emergence after craniotomy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Diltiazem
Labetalol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists