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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394222
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fujian Medical University Union Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: preoperative budesonide inhalation Drug: preoperative normal saline inhalation Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: preoperative budesonide inhalation
Placebo Comparator: Normal saline inhalation group
This group of participants were to receive4ml of preoperative normal saline inhalation for 10 to 15min.
 Drug: preoperative normal saline inhalation


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intrapulmonary shunt [ Time Frame: 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 ]
    Intrapulmonary shunt was assessed through blood gas analysis of sample taken


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394222


Sponsors and Collaborators
Fujian Medical University Union Hospital
Investigators
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Principal Investigator: Wenhua chen, M.D. Fujian Medical University Union Hospital
More Information
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Responsible Party: Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier: NCT03394222    
Other Study ID Numbers: FujianUnionAnethesia
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists