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

NCT01892332 | Completed

• 1 other identifier: 4-2013-0257
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  A blinded Assistant assess sensory and motor blockade in a 2-min intervals up to 60 minutes.

Study Arms (1)

lidocaine with fentanyl 75ug

OTHER

Drug: epidural block with lidocaine and fentanyl

Interventions

epidural block with lidocaine and fentanyl DRUG

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%.

lidocaine with fentanyl 75ug

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with any contraindication to epidural anesthesia were excluded.
• cognitive impairment
• coagulopathy
• allergy to lidocaine
• infection at the puncture site

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Anesthesia, Epidural; Lidocaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2013
• First Posted: July 4, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

KR (1)