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OpenTrials
Completed

NCT Number: NCT01608334

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

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.

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Key information

Conditions

Adequate Anesthesia With Unimpaired Motor Strength

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. time to achieve peak sensory block without unimpaired motor strength

    Time frame: 2 minites after injection intrathecally start

    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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 31, 2012
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.