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CompletedNCT01232270Updated Mar 6, 2013

The Optimal Effect Site Concentration of Propofol for Conscious Sedation in Elderly Male Patients Undergoing Urologic Surgery Under Spinal Anesthesia With or Without Intrathecal Fentanyl

An interventional study of propofol in Conscious Sedation Under Spinal Anesthesia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to male participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-06.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
Male
01

Study summary

Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in lowering propofol requirement for conscious sedation under spinal anesthesia.

02

Conditions studied

  • Conscious Sedation Under Spinal Anesthesia
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • patients with any co-morbidity
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    fentanyl

    Drug: propofol

  • Placebo comparator
    saline

    Drug: propofol

Interventions

  • Drugpropofol

    1.1 mcg/ml for initial effect site concentration during spinal anesthesia (The effect site concentration will be changed at each subject by Dixon's up-and-down method.)

    Also known as: Pofol®

06

What researchers measure

Primary outcomes

  1. Cerebral state index

    every 1 minute(up to 10-minute) after getting effect site concentration of propofol

    Time frame: 1 minute

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01232270
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Nov 2, 2010
Start date
Oct 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Mar 6, 2013

Study contacts

Tae-Dong Kwon, MD, Ph.D
principal investigator · Severance Hospital, Department of Anesthesia and Pain Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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