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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04810819
Other study ID # contrast-2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 30, 2021

Study information

Verified date June 2021
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date December 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics

Intervention

Drug:
Methylprednisolone 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.
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Pplat Airway pressure at different time points during operation 5 different time points during the operation
Primary Ppeak Peak airway pressure at different time points during operation 5 different time points during the operation