Changes in Cerebral Oxygenation During Deliberate Hypoten... | NCT00207987

Studies
Changes in Cerebral Oxygenation During Deliberate Hypotensive Anesthesia

NCT00207987

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

Nov 21, 2007Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Hypotension

Interventions

Not provided

Countries

Taiwan

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Nov 20, 2007

Last Update Posted Date

Nov 21, 2007Estimated

Description Module

Brief Summary

This is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia.

Detailed Description

The values of cerebral oximetry were analyzed between different stages of anesthetic management. The critical part of anesthetic management is to use the technique of controlled hypotension. The blood pressure was lowered to the level of MABP 50 or 60 mmHg depending on which group patients were assigned to.

The values of cerebral oximetry and side effects between 2 groups will be compared at the completion of data collection.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

40 patients are going to receive complex spine surgery.

Exclusion Criteria:

Neurologic diseases
Hepatic or renal impairment
Uncontrolled hypertension
Cardiovascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu C Liu, M.D.	Contact	886-4-22052121	3562	liuyc@seed.net.tw

Overall Officials

Name	Affiliation	Role
Yu C Liu, M.D.	Anesthetic Department, China Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthetic Department, China Medical University Hospital	Recruiting	Taichung		404	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided