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Study on the efficacy and safety of Remimazolam in one lung ventilation.

Study on the efficacy and safety of Remimazolam in one lung ventilation. - SEREV study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045849
Enrollment
70
Registered
2021-11-01
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Interventions

The standard drug group will be anesthetized with propofol administered by continuous intravenous infusion to maintain normal anesthesia. Basically, follow the package insert of the drug used. Anesthe

Sponsors

Kitasato University, School of Medicine, Department of Anesthesiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20 years and older undergoing lung surgery with one-lung ventilation and general anesthesia with epidural

Exclusion criteria

Exclusion criteria: If the research subject refuses to cooperate in the research. Contraindications to the use of anesthetics. If the subject has a disease that affects HPV. In the case of a procedure in which one lung ventilation is frequently released intraoperatively, such as surgery for pneumothorax. Patients with longitudinal tumors in the supine position who may require only short periods of one-lung ventilation. If the patient is scheduled to receive intraoperative cardiopulmonary ventilation. Patients with severe chronic lung disease (1 sec rate 50%or less, % lung capacity less than 80%)

Design outcomes

Primary

MeasureTime frame
To analyze the frequency and severity of hypoxemia in the remimazolam and propofol groups. During anesthesia, arterial partial pressure of oxygen, inhaled oxygen concentration, and P/F ratio (arterial partial pressure of oxygen/Inhaled oxygen concentration) immediately before one-lung ventilation, 30 minutes after the start of one-lung ventilation, and 1 hour after the start of six-lung ventilation.

Secondary

MeasureTime frame
Circulatory changes during anesthesia will be analyzed with respect to heart rate and blood pressure and the amount of boosting agents and other circulatory agonists used. Usage of boosting agents (e.g., neocinesinezine, ephedrine, atropine, and calcicol) during anesthesia Analysis of the presence and frequency of common intraoperative and postoperative complications associated with anesthesia. Intraoperative vital sign abnormalities and other adverse events During anesthesia, continuous monitoring of electrocardiogram, heart rate, percutaneous arterial blood oxygen saturation, and intra-arterial blood pressure will be performed using a monitoring device installed in each operating room to monitor for adverse events such as arrhythmia, deviations in heart rate and blood pressure, and respiratory depression. After administration, the patient should be evaluated for adverse events such as allergic symptoms (erythema, bronchospasm, anaphylaxis), delayed awakening, and convulsions in addition to the above. Analysis of the presence and frequency of other intraoperative and postoperative complications associated with anesthesia Presence of hypertension, hypotension, tachycardia, bradycardia, nausea, vomiting, delirium, intraoperative memory, pre- and post-anesthesia memory at the time of awakening and leaving the room - 24 hours after surgery

Countries

Japan

Contacts

Public ContactTakahiro Honda

Kitasato University School of Medicine, Department of Anesthesiology

serevstudy.contact@gmail.com0427788111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026