The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01232270

First received: November 1, 2010

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2010

Last Updated Date

March 4, 2013

Start Date ^ICMJE

October 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cerebral state index [ Time Frame: 1 minute ] [ Designated as safety issue: No ]

every 1 minute(up to 10-minute) after getting effect site concentration of propofol

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01232270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl

Official Title ^ICMJE

The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl

Brief Summary

Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in lowering propofol requirement for conscious sedation under spinal anesthesia.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Conscious Sedation Under Spinal Anesthesia

Intervention ^ICMJE

Drug: propofol

1.1 mcg/ml for initial effect site concentration during spinal anesthesia (The effect site concentration will be changed at each subject by Dixon's up-and-down method.)

Other Name: Pofol®

Study Arm (s)

Active Comparator: fentanyl
Intervention: Drug: propofol
Placebo Comparator: saline
Intervention: Drug: propofol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria:

patients with any co-morbidity

Gender

Male

Ages

60 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01232270

Other Study ID Numbers ^ICMJE

4-2010-0409

Has Data Monitoring Committee

Responsible Party

Yonsei University

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tae-Dong Kwon, MD, Ph.D

Severance Hospital, Department of Anesthesia and Pain Medicine

Information Provided By

Yonsei University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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