Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

One research assistant was tasked to give the interventional medication in indentical containers to the anesthesiologists(care provider) in charge of the participants for preoperative preparations.Both the participants and care providers were blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

preoperative budesonide inhalation

Intervention Type DRUG

Normal saline inhalation group

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

Group Type PLACEBO_COMPARATOR

preoperative normal saline inhalation

Intervention Type DRUG

Interventions

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preoperative budesonide inhalation

Intervention Type DRUG

preoperative normal saline inhalation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No