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Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients

NCT ID: NCT01608334

Last Updated: 2012-05-31

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

Brief Summary

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Adequate sensory block for surgical procedure without side effects and immediate mobilization after surgery are desirable anesthetic technique in various surgeries. Considering the sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP. Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of sufficient sensory block could be troublesome. In this randomized study, the investigators evaluated the spinal anesthetic characteristics following intrathecal administration of bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.

Detailed Description

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Conditions

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Adequate Anesthesia With Unimpaired Motor Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group A

Fentanyl

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.

Group B

Sufentanil

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.

Interventions

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Fentanyl

1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.

Intervention Type DRUG

Sufentanil

1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age over 65 \~ under 85yrears old
* male
* elderly patients undergoing TURP
* only spinal anesthesia
* patients consent about this study

Exclusion Criteria

* spine surgery History
* coagulopathy
* impaired communication
* impaired orientation
* DM complication neuropathy
* BMI \> 30 -\> overweight patients.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 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

Locations

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Severance hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0162

Identifier Type: -

Identifier Source: org_study_id