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

NCT01608334 | Completed

• 1 other identifier: 4-2011-0162
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adequate Anesthesia With Unimpaired Motor Strength

Outcome Measures

Primary Outcomes (1)

• time to achieve peak sensory block without unimpaired motor strength

  peak sensory \& sympathetic block level, time to peak sensory \& sympathetic block level, motor block level at peak sensory \& sympathetic block level, lowest BP and HR during spinal anestheisa, frequency of painkiller

  2 minites after injection intrathecally start

Study Arms (2)

group A

EXPERIMENTAL

Fentanyl

Drug: Fentanyl

Group B

ACTIVE COMPARATOR

Sufentanil

Drug: Sufentanil

Interventions

Fentanyl 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 A

Sufentanil 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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• spine surgery History
• coagulopathy
• impaired communication
• impaired orientation
• DM complication neuropathy
• BMI \> 30 -\> overweight patients.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Fentanyl; Sufentanil

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

KR (1)