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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012
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.

Condition Intervention
Adequate Anesthesia With Unimpaired Motor Strength
Drug: Fentanyl
Drug: Sufentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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

Enrollment: 56
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group A
Drug: Fentanyl
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.
Active Comparator: Group B
Drug: Sufentanil
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.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01608334

Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01608334     History of Changes
Other Study ID Numbers: 4-2011-0162
Study First Received: May 25, 2012
Last Updated: May 29, 2012

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local processed this record on May 25, 2017