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

Sponsor

Pusan National University Yangsan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05907525

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
One-Lung Ventilation Thoracic Surgery, Video-Assisted Remimazolam	Drug: Remimazolam Drug: 1% propofol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam group 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.	Drug: 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. Other Names: Byfavo
Active Comparator: Sevoflurane group 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). Remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.	Drug: 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. Other Names: Fresofol MCT 1%

Arm

Intervention/Treatment

Experimental: Remimazolam group

Drug: 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.

Other Names:

Byfavo

Active Comparator: Sevoflurane group

Drug: 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.

Other Names:

Fresofol MCT 1%

Outcome Measures

Primary Outcome Measures

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

Changes of PaO2 [During 60 minutes of OLV]
Compare the changes of PaO2 between two groups.
Changes of PaCO2 [During 60 minutes of OLV]
Compare the changes of PaCO2 between two groups.
Changes of P/F ratio [During 60 minutes of OLV]
Compare the changes of PaO2/FiO2 ratio between two groups.
The lowest PaO2 [During 60 minutes of OLV]
Compare the lowest PaO2 between two groups.
Changes of ORI [During 60 minutes of OLV]
Compare the changes of oxygen reserve index between two groups.
Changes of MAP [During 60 minutes of OLV]
Compare the changes of mean arterial pressure between two groups.

Other Outcome Measures

cardiac output [During 60 minutes of OLV]
Compare the cardiac output using Masimo LiDCO™ hemodynamic monitoring system
airway pressure [During 60 minutes of OLV]
Compare the peak airway pressure between two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%