NCT01408524

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_1 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

July 11, 2011

Last Update Submit

March 31, 2014

Conditions

HypertensionCraniotomy

Keywords

HypertensionemergencecraniotomyHypertension during the emergence after craniotomy

Outcome Measures

Primary Outcomes (1)

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

    3 hours

Secondary Outcomes (2)

  • mean doses of the study drugs

    3hr

  • the number of patients with Adverse Events as a Measure of Safety and Tolerability

    6 hour

Study Arms (2)

Diltiazem

ACTIVE COMPARATOR

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Drug: Diltiazem

Labetalol

ACTIVE COMPARATOR

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Drug: Labetalol

Interventions

DiltiazemDRUG

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Also known as: Herbessor
Diltiazem
LabetalolDRUG

2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence

Also known as: Avexa
Labetalol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who scheduled for craniotomy for tomor removal

You may not qualify if:

  • allergic to labetalol or diltiazem
  • Bradycardia \< 60 beat/min
  • Second or third degree heart block
  • Severe asthma or severe COPD
  • Brain stem tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

DiltiazemLabetalol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAmines

Study Officials

  • Busara - Sirivanasandha, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Miss

Study Record Dates

First Submitted

July 11, 2011

First Posted

August 3, 2011

Study Start

February 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2013

Last Updated

April 1, 2014

Record last verified: 2014-03