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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Hypertension, Craniotomy

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Trial Information

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


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

Type of Study:

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

Outcome Measure:

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

Outcome Time Frame:

3 hours

Safety Issue:

Yes

Principal Investigator

Busara - Sirivanasandha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand

Authority:

Thailand: Ethical Committee

Study ID:

594/2552(EC4)

NCT ID:

NCT01408524

Start Date:

February 2010

Completion Date:

March 2012

Related Keywords:

  • Hypertension
  • Craniotomy
  • Hypertension
  • emergence
  • craniotomy
  • Hypertension during the emergence after craniotomy
  • Hypertension

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