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Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation

Not Applicable
Completed
Conditions
Remimazolam
One-Lung Ventilation
Thoracic Surgery, Video-Assisted
Interventions
Registration Number
NCT05907525
Lead Sponsor
Pusan National University Yangsan Hospital
Brief Summary

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.

Detailed Description

One lung ventilation (OLV) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. During one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. This is known as hypoxic pulmonary vasoconstriction (HPV). Therefore, by using HPV, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation.

The two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. Previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (MAC) resulted in similar changes in shunt fraction as did propofol.

However, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
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%

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sevoflurane group1% propofolTo 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). Remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.
Remimazolam groupRemimazolamTo 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.
Primary Outcome Measures
NameTimeMethod
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)

compare the arterial oxygenation after 30 minutes of one lung ventilation between two groups

Secondary Outcome Measures
NameTimeMethod
Changes of PaCO2During 60 minutes of OLV

Compare the changes of PaCO2 between two groups.

Changes of ORIDuring 60 minutes of OLV

Compare the changes of oxygen reserve index between two groups.

Changes of PaO2During 60 minutes of OLV

Compare the changes of PaO2 between two groups.

Changes of P/F ratioDuring 60 minutes of OLV

Compare the changes of PaO2/FiO2 ratio between two groups.

The lowest PaO2During 60 minutes of OLV

Compare the lowest PaO2 between two groups.

Changes of MAPDuring 60 minutes of OLV

Compare the changes of mean arterial pressure between two groups.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital

🇰🇷

Yangsan, Please Select, Korea, Republic of

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