Skip to main content
Clinical Trials/NCT04810819
NCT04810819
Unknown
Not Applicable

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

Qianfoshan Hospital0 sites110 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;
Conditions
Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics
Sponsor
Qianfoshan Hospital
Enrollment
110
Primary Endpoint
Pplat
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Qianfoshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lili Cao

professor

Qianfoshan Hospital

Eligibility Criteria

Inclusion Criteria

  • After fully understanding the purpose and significance of the trial, the patients voluntarily participated in the trial and signed the informed consent;
  • The type of operation was general anesthesia and thoracoscopic lobectomy;
  • Age 18-75 years old, including boundary value, gender is not limited;
  • BMI 18-26kg / m2;
  • ASA grade I-II; no mental disorder, normal consciousness, normal communication;
  • No contraindications of methylprednisolone and dihydroxypropyltheophylline.

Exclusion Criteria

  • There were diseases of immune, endocrine, nervous and mental system before operation, and serious dysfunction of heart, liver and kidney;
  • Take immunosuppressive drugs and non steroidal anti-inflammatory drugs before operation;
  • Respiratory tract infection (cough, expectoration, suffocation, etc.) in recent 1 month; pneumonia, bronchitis, etc. on CT;
  • History of chronic pulmonary disease, including but not limited to asthma, pulmonary abscess, tuberculosis, chronic bronchitis, etc;
  • FEV1 \< 50%;
  • Oxygen saturation was lower than 90% and airway pressure was higher than 40 cm H20;
  • Continuous hypotension or hypertension during the operation; intraoperative blood loss \> 1000ml;
  • Allergic to methylprednisolone or dihydroxypropyltheophylline;
  • There are any other situations that the researchers think are not suitable for inclusion.

Arms & Interventions

Experimental group

Intervention: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;

control group

Intervention: Placebo

Outcomes

Primary Outcomes

Pplat

Time Frame: 5 different time points during the operation

Airway pressure at different time points during operation

Ppeak

Time Frame: 5 different time points during the operation

Peak airway pressure at different time points during operation

Similar Trials