NCT02191371

Brief Summary

One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate during one-lung ventilation in the perspective of oxygenation and microcirculation. The investigators hypothesized that intravenous and inhalational anesthetics may affect oxygenation and microcirculation differently during one-lung ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 13, 2016

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

July 7, 2014

Last Update Submit

October 12, 2016

Conditions

Mechanical Ventilation Complication

Keywords

oxygenationmicrocirculationone-lung ventilationthoracic surgery

Outcome Measures

Primary Outcomes (1)

  • arterial partial pressure of oxygen

    Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.

    30 min after one-lung ventilation

Secondary Outcomes (1)

  • recovery slope

    30 min after one-lung ventilation

Other Outcomes (1)

  • blood pressure

    30 min after one-lung ventilation

Study Arms (2)

propofol

EXPERIMENTAL

Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4\~5 mcg/ml, during general anesthesia

Drug: propofol

desflurane

EXPERIMENTAL

Desflurane is used as a maintenance anesthetic to patients in the desflurane group. Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6\~8 vol% during general anesthesia

Drug: desflurane

Interventions

propofolDRUG

Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.

Also known as: propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)
propofol
desfluraneDRUG

Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.

Also known as: desflurane (Suprane(R), Baxter Healthcare)
desflurane

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing thoracic surgery including one-lung ventilation

You may not qualify if:

  • refuse to enroll
  • BMI over 30 kg/m(2)
  • severe obstructive or restrictive lung disease
  • preoperative supplemental oxygen, intubated, or mechanical ventilatory support
  • preoperative arterial partial pressure of oxygen \< 60 mmHg
  • pregnancy
  • history of coronary artery disease
  • preoperative continuous infusion of vasopressor or inotropes
  • cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.

    PMID: 28100177DERIVED

MeSH Terms

Interventions

PropofolDesflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Yunseok Jeon, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 16, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 13, 2016

Record last verified: 2014-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)