Clinical trial NCT05907525: Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation
Official title: Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One-Lung Ventilation
Thoracic Surgery, Video-Assisted
Remimazolam
Keywords: remimazolam
one-lung ventilation
arterial oxygenation
hypoxic pulmonary vasoconstriction
sevoflurane
thoracic surgery
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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%

Primary outcomes:
measure: PaO2 after 30 minutes of OLV (T2)
timeFrame: 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)
Secondary outcomes:
measure: Changes of PaO2
timeFrame: During 60 minutes of OLV
measure: Changes of PaCO2
timeFrame: During 60 minutes of OLV
measure: Changes of P/F ratio
timeFrame: During 60 minutes of OLV
measure: The lowest PaO2
timeFrame: During 60 minutes of OLV
measure: Changes of ORI
timeFrame: During 60 minutes of OLV
measure: Changes of MAP
timeFrame: During 60 minutes of OLV
Other outcomes:
measure: cardiac output
timeFrame: During 60 minutes of OLV
measure: airway pressure
timeFrame: During 60 minutes of OLV
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Please Select
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Hee Young Kim, MD. PhD
role: STUDY_CHAIR
References: