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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01408524
First received: July 11, 2011
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertension
Craniotomy
 Drug: Diltiazem
Drug: Labetalol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The number of the patients who have systolic blood pressure below 140 mmHg [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean doses of the study drugs [ Time Frame: 3hr ] [ Designated as safety issue: Yes ]
  • the number of patients with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 184
Study Start Date: February 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408524

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

No publications provided

Responsible Party: Busara Sirivanasandha, Mahidol University
ClinicalTrials.gov Identifier: NCT01408524     History of Changes
Other Study ID Numbers: 594/2552(EC4)
Study First Received: July 11, 2011
Last Updated: August 2, 2011
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013