Clinical trial

Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation: a Prospective Randomized Controlled Study

Name

05-2023-133

Description

The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

Trial arms

Trial start

2023-06-29

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Treatment

Remimazolam

To induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg.

Arms:

Remimazolam group

Other names:

Byfavo

1% propofol

To induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC), and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia. Inspired oxygen fraction (FiO2) 1.0 is used during mask ventilation and tracheal intubation. During two lung ventilation (TLV), tidal volumes (8mL/kg predicted body weight), positive end-expiratory pressure (PEEP) 5cmH2O with FiO2 0.3 is applied. At the start of one lung ventilation(OLV), tidal volumes (5mL/kg predicted body weight), PEEP 5cmH2O with FiO2 0.8 is applied. Intraoperative ventilatory frequency is 12 breaths/min, subsequently adjusted to maintain end tidal CO2(ETCO2) ranged between 35-40mmHg.

Arms:

Sevoflurane group

Other names:

Fresofol MCT 1%

Size

Primary endpoint

PaO2 after 30 minutes of OLV (T2)

arterial blood sampling will be taken over four times: T0 (after 10 minute of TLV in lateral decubitus position), T1 (after 15 minutes of OLV), T2 (after 30 minutes of OLV), T3 (after 60 minutes of OLV)

Eligibility criteria

Inclusion Criteria: * Patients undergoing video-assisted thoracoscopic surgery * 19 years of age or older, less than 80 years old * The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status Exclusion Criteria: * Patients with known allergy to benzodiazepine, propofol * Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Patients with hypersensitivity to Dextran40 * Patients with end stage renal disease requiring hemodialysis * Patients with history of acute angle glaucoma * Emergency operation * Patients with unstable hemodynamics requiring inotropics * Patients with preoperative oxygen supplement * Preoperative forced expiratory volume (FEV1) less than 40% of predicted * Preoperative ejection fraction less than 50%

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 58, 'type': 'ESTIMATED'}}

Updated at

2023-09-26

1 organization

2 products

4 indications

Organization

Pusan National University Yangsan Hospital

Product

Remimazolam

Indication

One-lung ventilation

Indication

Thoracic Surgical Procedures

Indication

Video-Assisted

Indication

Remimazolam

Product

Propofol