ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients

NCT ID: NCT03704441

Last Updated: 2022-03-21

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-09-01

Brief Summary

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As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe complication after spinal anesthesia. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

Detailed Description

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As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe hypotension and vital unstability due to unintentional high sensory and motor blocks. These complications are due to the decreased cerebrospinal fluid volume with increase of age. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

Conditions

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Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bupivacaine 6mg

bupivacaine 6mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 7mg

bupivacaine 7mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 8mg

bupivacaine 8mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 9mg

bupivacaine 9mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 10mg

bupivacaine 10mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 11mg

bupivacaine 11mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

bupivacaine 12mg

bupivacaine 12mg

Group Type OTHER

Bupivacaine

Intervention Type DRUG

bupivacaine dose

Interventions

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Bupivacaine

bupivacaine dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for TURP \& HoLEP under spinal anesthesia
* Male between 65 and 100
* The American Society of Anesthesiologists physical status class 1 or 2

Exclusion Criteria

* Patients with coagulopathy
* Patients with infectious disease
* Patients with a drug allergy
* Patients under 50kg or over 100kg
* In case of switching to general anesthesia
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eun Mi Choi, MD

Role: STUDY_DIRECTOR

Hallym University Kangnam Sacred Heart Hospital

Locations

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Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KangnamAnes

Identifier Type: -

Identifier Source: org_study_id

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