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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232270

Enrollment

Registered

2010-11-02

Start date

2010-10-31

Completion date

2011-07-31

Last updated

2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation Under Spinal Anesthesia

Brief summary

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

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.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

60 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion criteria

* patients with any co-morbidity

Design outcomes

Primary

Measure	Time frame	Description
Cerebral state index	1 minute	every 1 minute(up to 10-minute) after getting effect site concentration of propofol

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026