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Clinical Trials/NCT03394222
NCT03394222
Completed
Phase 4

Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation

Fujian Medical University Union Hospital0 sites50 target enrollmentJuly 2016

Overview

Phase
Phase 4
Intervention
preoperative normal saline inhalation
Conditions
Lung Cancer
Sponsor
Fujian Medical University Union Hospital
Enrollment
50
Primary Endpoint
Arterial blood oxygenation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation

Detailed Description

Population: The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will include 50 subjects of both gender and any race or ethnicity. Procedures: Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:Budesonide inhalation group vs Normal saline inhalation group Study Duration: Overall duration of the study is 10 months.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
April 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(BMI)18-27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.

Exclusion Criteria

  • FEV1/FVC\<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock.

Arms & Interventions

Normal saline inhalation group

This group of participants were to receive4ml of preoperative normal saline inhalation for 10 to 15min.

Intervention: preoperative normal saline inhalation

Budesonide inhalation group

This group of participants were to receive 2mg/4ml of preoperative budesonide inhalation (Khartoum Road NORTH RYDE NSW 2113 Australia. AstraZeneca Pty Ltd) for 10 to 15min.

Intervention: preoperative budesonide inhalation

Outcomes

Primary Outcomes

Arterial blood oxygenation

Time Frame: Arterial blood oxygenation was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation.

Arterial blood oxygenation was assessed through blood gas analysis of sample taken from radial artery

Secondary Outcomes

  • Intrapulmonary shunt(Intrapulmonary shunt was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation)

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