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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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


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

Ages Eligible for Study:   60 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01232270     History of Changes
Other Study ID Numbers: 4-2010-0409
Study First Received: November 1, 2010
Last Updated: March 4, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 16, 2013