Control of Emergence Blood Pressure During Craniotomy for... | NCT01408524

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

NCT01408524

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Apr 1, 2014Estimated

Enrollment

184Actual

Phase

Phase 1Phase 2

Conditions

Hypertension
Craniotomy

Interventions

Diltiazem
Labetalol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Aug 2, 2011

First Posted Date

Aug 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2014

Last Update Posted Date

Apr 1, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study was randomized equivalence trial

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diltiazem	Drug	2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence	Diltiazem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of the patients who have systolic blood pressure below 140 mmHg		3 hours

Secondary Outcomes

Measure	Description	Time Frame
mean doses of the study drugs		3hr
the number of patients with Adverse Events as a Measure of Safety and Tolerability		6 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Busara - Sirivanasandha, MD	Department of Anesthesiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004110	Diltiazem
D007741	Labetalol

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided