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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide inhalation group | Experimental | 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. |
|
| Normal saline inhalation group | Placebo Comparator | This group of participants were to receive4ml of preoperative normal saline inhalation for 10 to 15min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative budesonide inhalation | Drug |
| ||
| preoperative normal saline inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood oxygenation | Arterial blood oxygenation was assessed through blood gas analysis of sample taken from radial artery | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrapulmonary shunt | Intrapulmonary shunt was assessed through blood gas analysis of sample taken | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenhua chen, M.D. | Fujian Medical University Union Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 25, 2018 | |
| Reset | Oct 8, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 25, 2018 | Oct 8, 2018 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
| Drug |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |