Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory DynamicsNCT04810819
Clinical Study of the Effect of Methylprednisolone Combined
A study testing Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; in people with Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics, run by Qianfoshan Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics
- What is being tested?
- Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: 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.
- Being tested
- Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; |
| control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pplat
Airway pressure at different time points during operation
Measured: 5 different time points during the operation
Ppeak
Peak airway pressure at different time points during operation
Measured: 5 different time points during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory DynamicsStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810819
- Sponsor's protocol ID
- contrast-2021
- Status last verified
- Jun 2021
- First submitted
- 21 Mar 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT04810819
- Acronym / sponsor ID
- contrast-2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; |
| control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental group |
| PlaceboPlacebo | Drug | control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline; in people with Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pplat (time frame: 5 different time points during the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.