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

M

Mahidol University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Hypertension
Craniotomy

Treatments

Drug: Diltiazem
Drug: Labetalol

Study type

Interventional

Funder types

Other

Identifiers

NCT01408524
594/2552(EC4)

Details and patient eligibility

About

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.

Full description

The study was randomized equivalence trial

Enrollment

184 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

184 participants in 2 patient groups

Diltiazem
Active Comparator group
Description:
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Treatment:
Drug: Diltiazem
Labetalol
Active Comparator group
Description:
2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
Treatment:
Drug: Labetalol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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