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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

Sponsors and Collaborators

Mahidol University

Investigators

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

More Information

• Responsible Party: busara sirivanasandha, Miss, Mahidol University
• ClinicalTrials.gov Identifier: NCT01408524
• Other Study ID Numbers: 594/2552(EC4)
• First Posted: August 3, 2011
• 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; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists