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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
busara sirivanasandha, Mahidol University
ClinicalTrials.gov Identifier:
NCT01408524
First received: July 11, 2011
Last updated: March 31, 2014
Last verified: March 2014
  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:


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: 6 hour ] [ Designated as safety issue: Yes ]

Enrollment: 184
Study Start Date: February 2010
Study Completion Date: December 2013
Primary Completion Date: November 2012 (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

Detailed Description:

The study was randomized equivalence trial

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Miss, Mahidol University
ClinicalTrials.gov Identifier: NCT01408524     History of Changes
Other Study ID Numbers: 594/2552(EC4)
Study First Received: July 11, 2011
Last Updated: March 31, 2014
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
Labetalol
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator 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 July 29, 2014