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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608334
First Posted: May 31, 2012
Last Update Posted: May 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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 (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
Fentanyl
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
Sufentanil
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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608334


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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01608334     History of Changes
Other Study ID Numbers: 4-2011-0162
First Submitted: May 25, 2012
First Posted: May 31, 2012
Last Update Posted: May 31, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General