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The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients

Primary Purpose

BPH( Benign Prostate Hyperplasia), TURP(Transurethral Resection of Prostate)

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
epidural block with lidocaine and fentanyl
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH( Benign Prostate Hyperplasia)

Eligibility Criteria

65 Years - 85 Years (Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1 -3, patients scheduled for TURP( transurethral resection of prostate) were included

Exclusion Criteria:

  • Patients with any contraindication to epidural anesthesia were excluded.

    • cognitive impairment
    • coagulopathy
    • allergy to lidocaine
    • infection at the puncture site

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lidocaine with fentanyl 75ug

Arm Description

Outcomes

Primary Outcome Measures

Determining the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate(TURP) in elderly patients
The occurrence of sensory block up to at T 12 and motor function score of 3 or more on the modified Bromage scale were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anesthetic procedure.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2013
Last Updated
July 24, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01892332
Brief Title
The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine may cause excessive motor block and unwanted side effects such as nausea, vomiting and hypotension. This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate in elderly patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH( Benign Prostate Hyperplasia), TURP(Transurethral Resection of Prostate)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine with fentanyl 75ug
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
epidural block with lidocaine and fentanyl
Intervention Description
The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting concentration of lidocaine was 1.5 % mixed with fentanyl 75 ug. All patients receive 13mL of lidocaine with fentanyl 75ug. The concentration of lidocaine for subsequent patients is determined by the outcome in the previous patient according to up and down sequential allocation in 0.1% increments. In the case of block failure, the concentration of lidocaine was increased by 0.1%. Conversely, block success resulted in a reduction in concentration by 0.1%.
Primary Outcome Measure Information:
Title
Determining the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate(TURP) in elderly patients
Description
The occurrence of sensory block up to at T 12 and motor function score of 3 or more on the modified Bromage scale were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anesthetic procedure.
Time Frame
A blinded Assistant assess sensory and motor blockade in a 2-min intervals up to 60 minutes.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1 -3, patients scheduled for TURP( transurethral resection of prostate) were included Exclusion Criteria: Patients with any contraindication to epidural anesthesia were excluded. cognitive impairment coagulopathy allergy to lidocaine infection at the puncture site
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients

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