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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics
• Intervention / Treatment: Drug: Placebo; Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Drug: Placebo; Placebo
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Dyphylline
• Other Study ID Numbers: contrast-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No