Clinical Study of the Effect of Methylprednisolone Combined

NCT04810819 | Unknown

• 1 other identifier: contrast-2021
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;

control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; DRUG

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.

Experimental group

Placebo DRUG

Placebo

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 23, 2021
• Study Start: July 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06