Clinical Study of the Effect of Methylprednisolone Combined

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04810819

Collaborator

(none)

110

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics	Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	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 Comparator: control group	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Experimental group

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 Comparator: control group

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Pplat [5 different time points during the operation]
Airway pressure at different time points during operation
Ppeak [5 different time points during the operation]
Peak airway pressure at different time points during operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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;

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:

1. 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.