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

JRCT ID: jRCT1031210446

Registered date:24/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung Neoplasms
• Date of first enrollment: 13/12/2021
• Target sample size: 70
• Study type: Interventional

Intervention(s)

The following continuous intravenous infusion is used to maintain normal anesthesia. Basically, follow the package insert of the drug used. Anesthesia should be administered according to a predetermined protocol based on the administration method and dosage according to the package insert.

Standard treatment (use) drug: Propofol (1% Diprivan Injection Kit)
Duration of administration: 1 day
Anticipated side effects: bradycardia, hypotension, respiratory depression, delayed awakening, shock/anaphylaxis, erythema, headache, nausea, vomiting, arrhythmia, bronchospasm, epileptic body movements, ventricular extrasystoles, pulmonary edema, rhabdomyolysis, vascular pain, etc.

Test drug: Remimazolam besylate (Anerem 50mg for intravenous injection)
Duration of administration: 1 day
Anticipated side effects: bradycardia, hypotension, respiratory depression, delayed arousal, shock/anaphylaxis, erythema, headache, nausea, vomiting, chills, delirium, etc.

Outcome(s)

Primary Outcome

To analyze the frequency and degree of hypoxemia in the remimazolam and propofol groups.
Values of arterial blood oxygen saturation, partial pressure of arterial blood oxygen, inspiratory oxygen concentration, and P/F ratio (partial pressure of arterial blood oxygen/inspiratory oxygen concentration) during anesthesia, immediately before, 30 minutes after, and 1 hour after the start of one-lung ventilation.

Secondary Outcome

Analysis of circulatory changes during anesthesia will be performed for heart rate and blood pressure and the amount of circulatory agonists such as pressure elevators used.
The amount of pressure-boosting drugs (neosynergine, ephedrine, atropine, carcicol, etc.) used during anesthesia, heart rate during anesthesia (values every 5 minutes will be extracted and the average value will be calculated), and blood pressure during anesthesia (values every 5 minutes will be extracted and the average value will be calculated)

The presence and frequency of general intraoperative and postoperative complications associated with anesthesia will be analyzed.
Intraoperative vital sign abnormalities and other adverse events
During anesthesia, electrocardiogram, heart rate, transcutaneous arterial oxygen saturation, and arterial blood pressure will be continuously measured using the monitoring equipment always available in each operating room, and the presence of adverse events such as arrhythmia, deviation of heart rate and blood pressure, and respiratory depression will be monitored. After administration, in addition to the above, evaluate for side effects such as allergic symptoms (erythema, bronchospasm, anaphylaxis), delayed awakening, and convulsions.
Analysis of the presence and frequency of other intraoperative and postoperative complications associated with anesthesia
Presence or absence of hypertension, hypotension, tachycardia, bradycardia, nausea, vomiting, delirium, intraoperative memory, and pre- and post-anesthesia memory at the time of awakening and leaving the room to 24 hours after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients aged 20 years and older undergoing lung surgery with one-lung ventilation and general anesthesia with epidural

Exclude 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%)

Related Information

• Primary Sponsor: Hirotsugu Okamoto