NCT01232270

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

November 1, 2010

Last Update Submit

March 4, 2013

Conditions

Conscious Sedation Under Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Cerebral state index

    every 1 minute(up to 10-minute) after getting effect site concentration of propofol

    1 minute

Study Arms (2)

fentanyl

ACTIVE COMPARATOR
Drug: propofol

saline

PLACEBO COMPARATOR
Drug: propofol

Interventions

propofolDRUG

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.)

Also known as: Pofol®
fentanylsaline

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elderly male patients undergoing urologic surgery under spinal anesthesia

You may not qualify if:

  • patients with any co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Tae-Dong Kwon, MD, Ph.D

    Severance Hospital, Department of Anesthesia and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

KR(1)