The Effects of Anesthetic Method on Cerebral Oxygen Satur... | NCT01147146

Studies
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery

NCT01147146

Sponsor

Yonsei University

Status

Completed

Last Update Posted

May 13, 2011Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Surgery

Interventions

propofol, fentanyl, atracurium
bupivacaine
bupivacaine, Midazolam

Countries

South Korea

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

May 2011

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

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Jun 17, 2010

First Posted Date

Jun 22, 2010Estimated

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

May 12, 2011

Last Update Posted Date

May 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
propofol, fentanyl, atracurium	Drug	general anesthesia	propofol 2mg/kg, fentanyl 50mg, atracurium 0.5mg/kg
bupivacaine	Drug	spinal anesthesia	bupivacaine 8-10mg
bupivacaine, Midazolam	Drug	spinal anesthesia & sedation	Bupivacine 8-10mg, Midazolam 0.5mg/kg

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery

Exclusion Criteria:

cardiovascular, renal, liver disease, or cerebrovascular disorder

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeong-Yeon Hong, MD	Anesthesiology & Pain Medicine, Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital, Yonsei University College of Medicine		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D005283	Fentanyl
D001279	Atracurium
D002045	Bupivacaine
D008874	Midazolam

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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