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Clinical Study of the Effect of Methylprednisolone Combined

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04810819
Enrollment
110
Registered
2021-03-23
Start date
2021-07-01
Completion date
2021-12-30
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics

Brief summary

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.

Interventions

DRUGMethylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;

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.

DRUGPlacebo

Placebo

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pplat5 different time points during the operationAirway pressure at different time points during operation
Ppeak5 different time points during the operationPeak airway pressure at different time points during operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026