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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:
ClinicalTrials.gov Identifier:
NCT01232270
First Posted: November 2, 2010
Last Update Posted: March 6, 2013
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
Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in lowering propofol requirement for conscious sedation under spinal anesthesia.

Condition Intervention
Conscious Sedation Under Spinal Anesthesia Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Cerebral state index [ Time Frame: 1 minute ]
    every 1 minute(up to 10-minute) after getting effect site concentration of propofol


Enrollment: 43
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fentanyl 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®
Placebo Comparator: saline 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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria:

  • patients with any co-morbidity
  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): NCT01232270


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Tae-Dong Kwon, MD, Ph.D Severance Hospital, Department of Anesthesia and Pain Medicine
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01232270     History of Changes
Other Study ID Numbers: 4-2010-0409
First Submitted: November 1, 2010
First Posted: November 2, 2010
Last Update Posted: March 6, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Anesthetics
Propofol
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia