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

NCT ID: NCT01232270

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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Conditions

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Conscious Sedation Under Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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fentanyl

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

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.)

saline

Group Type PLACEBO_COMPARATOR

propofol

Intervention Type DRUG

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.)

Interventions

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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.)

Intervention Type DRUG

Other Intervention Names

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PofolĀ®

Eligibility Criteria

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Inclusion Criteria

* elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria

* patients with any co-morbidity
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tae-Dong Kwon, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Department of Anesthesia and Pain Medicine

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2010-0409

Identifier Type: -

Identifier Source: org_study_id

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