Clinical Study of the Effect of Methylprednisolone Combined

Study Overview
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Brief Summary
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Through the design of RCT study, the preoperative use of drugs (methylprednisolone + dihydroxypropyltheophylline) as intervention measures, the patients undergoing thoracoscopic lobectomy as the main research object, through the comparison of two groups of patients with intraoperative respiratory dynamics index and postoperative complications, to explore a more effective perioperative management method.

Official Title
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Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy

Conditions
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Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics

Intervention / Treatment
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* Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. After fully understanding the purpose and significance of the trial, the patients voluntarily participated in the trial and signed the informed consent; 2. The type of operation was general anesthesia and thoracoscopic lobectomy; 3. Age 18-75 years old, including boundary value, gender is not limited; 4. BMI 18-26kg / m2; 5. ASA grade I-II; no mental disorder, normal consciousness, normal communication; 6. No contraindications of methylprednisolone and dihydroxypropyltheophylline. Exclusion Criteria: 1. There were diseases of immune, endocrine, nervous and mental system before operation, and serious dysfunction of heart, liver and kidney; 2. Take immunosuppressive drugs and non steroidal anti-inflammatory drugs before operation; 3. Respiratory tract infection (cough, expectoration, suffocation, etc.) in recent 1 month; pneumonia, bronchitis, etc. on CT; 4. History of chronic pulmonary disease, including but not limited to asthma, pulmonary abscess, tuberculosis, chronic bronchitis, etc; 5. FEV1 < 50%; 6. Oxygen saturation was lower than 90% and airway pressure was higher than 40 cm H20; 7. Continuous hypotension or hypertension during the operation; intraoperative blood loss > 1000ml; 8. Allergic to methylprednisolone or dihydroxypropyltheophylline; 9. There are any other situations that the researchers think are not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;<br>* Before anesthesia induction, 80 mg methylprednisolone and 100 ml saline were given intravenously, and 0.25 g dihydroxypropyltheophylline and 100 ml normal saline were given intravenously.<br>|
| Placebo Comparator: control group<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pplat | Airway pressure at different time points during operation | 5 different time points during the operation | 
| Ppeak | Peak airway pressure at different time points during operation | 5 different time points during the operation |