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

March 4, 2013 updated by: Yonsei University
Since intrathecal fentanyl is known to sedation effect, intrathecal fentanyl will result in lowering propofol requirement for conscious sedation under spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • elderly male patients undergoing urologic surgery under spinal anesthesia

Exclusion Criteria:

  • patients with any co-morbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Pofol®
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 Names:
  • Pofol®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Tae-Dong Kwon, MD, Ph.D, Severance Hospital, Department of Anesthesia and Pain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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