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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01232270
First received: November 1, 2010
Last updated: March 4, 2013
Last verified: March 2013

November 1, 2010
March 4, 2013
October 2010
July 2011   (final data collection date for primary outcome measure)
Cerebral state index [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
every 1 minute(up to 10-minute) after getting effect site concentration of propofol
Same as current
Complete list of historical versions of study NCT01232270 on ClinicalTrials.gov Archive Site
Not Provided
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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
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Conscious Sedation Under Spinal Anesthesia
Drug: propofol
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.)
Other Name: Pofol®
  • Active Comparator: fentanyl
    Intervention: Drug: propofol
  • Placebo Comparator: saline
    Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria:

  • patients with any co-morbidity
Male
60 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01232270
4-2010-0409
No
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Tae-Dong Kwon, MD, Ph.D Severance Hospital, Department of Anesthesia and Pain Medicine
Yonsei University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP