NCT00935571

Brief Summary

The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
unknown

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, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

July 8, 2009

Last Update Submit

July 8, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of pain

    3 and 6 months later after operation

Secondary Outcomes (1)

  • pain characters

    3 and 6 months later after operation

Study Arms (1)

Group I, Group II

Group I: anesthetized with TIVA (Propofol + Remifentanil) Group II: anesthetized with inhalation (sevoflurane)

Drug: propofol, remifentanil, sevoflurane

Interventions

Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)

Also known as: diprivan, ultiva
Group I, Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled to undergo elective thoracotomy of lung surgery

You may qualify if:

  • patients undergo elective thoracotomy of lung surgery

You may not qualify if:

  • emergency operation age under 18 years patients with unstable hemodynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.

    PMID: 11394926BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

PropofolRemifentanilSevoflurane

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • In Cheol Choi, MD, PhD

    Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations