NCT03015350

Brief Summary

16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time interval of 10 minutes after one lung ventilation started. All blood samples will be assess in Gas Chromatography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

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

December 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 5, 2018

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

December 27, 2016

Last Update Submit

March 2, 2018

Conditions

Keywords

blood sevoflurane concentrationblood desflurane concentrationone lung ventilation

Outcome Measures

Primary Outcomes (1)

  • Measurement of blood levels of Sevoflurane and Desflurane

    Data collections will be ensured from arterial and venous blood sample and than samples will be assessed with gas chromatography and blood sevoflurane and desflurane level will be measured. Blood samples will take every 10 minutes. Only blood levels of sevoflurane and desflurane will be assessed.

    from 40th minute to the end of the operation

Secondary Outcomes (1)

  • determine of ventilation-perfusion mismatch with p(A-a)O2

    from 40th minute to the end of the one lung ventilation

Study Arms (4)

two lung ventilation of Sevoflurane

In GroupSa, 1,5 % sevoflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.

Drug: Sevoflurane

one lung ventilation of Sevoflurane

In GroupSa, 1,5 % sevoflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.

Drug: Sevoflurane

two lung ventilation of Desflurane

In GroupSa, 6 % desflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.

Drug: Desflurane

one lung ventilation of desflurane

In GroupSa, 6 % desflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.

Drug: Desflurane

Interventions

Measurement of blood desflurane level during one lung ventilation

Also known as: Blood sevoflurane level
one lung ventilation of Sevofluranetwo lung ventilation of Sevoflurane

Measurement of blood desflurane level during one lung ventilation

Also known as: Blood desflurane level
one lung ventilation of desfluranetwo lung ventilation of Desflurane

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

16 patients with ASA I-III who undergo thoracotomy or abdominal surgery

You may qualify if:

  • Who undergo thoracotomy or abdominal surgery

You may not qualify if:

  • ASA IV and up patients
  • Patients who taken inotropic agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Biricik

Adana, In the USA Or Canada, Please Select..., 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

SevofluraneDesflurane

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Ebru Biricik, MD

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Anesthesiology specialist

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 10, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 5, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations