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

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ClinicalTrials.gov Identifier: NCT05907525
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Kim Hee Young, Pusan National University Yangsan Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : June 29, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Fresofol MCT 1%


Outcome Measures
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Primary Outcome Measures :
  1. PaO2 after 30 minutes of OLV (T2) [ Time Frame: 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 :
  1. Changes of PaO2 [ Time Frame: During 60 minutes of OLV ]
    Compare the changes of PaO2 between two groups.

  2. Changes of PaCO2 [ Time Frame: During 60 minutes of OLV ]
    Compare the changes of PaCO2 between two groups.

  3. Changes of P/F ratio [ Time Frame: During 60 minutes of OLV ]
    Compare the changes of PaO2/FiO2 ratio between two groups.

  4. The lowest PaO2 [ Time Frame: During 60 minutes of OLV ]
    Compare the lowest PaO2 between two groups.

  5. Changes of ORI [ Time Frame: During 60 minutes of OLV ]
    Compare the changes of oxygen reserve index between two groups.

  6. Changes of MAP [ Time Frame: During 60 minutes of OLV ]
    Compare the changes of mean arterial pressure between two groups.


Other Outcome Measures:
  1. cardiac output [ Time Frame: During 60 minutes of OLV ]
    Compare the cardiac output using Masimo LiDCO™ hemodynamic monitoring system

  2. airway pressure [ Time Frame: During 60 minutes of OLV ]
    Compare the peak airway pressure between two groups


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907525


Contacts
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Contact: Jung-Pil Yoon, MD 820553602129 wizdumb@naver.com

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Please Select, Korea, Republic of, 50612
Contact: Jung-Pil Yoon, MD         
Contact: Hee Young Kim, MD. PhD         
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Study Chair: Hee Young Kim, MD. PhD Pusan National University Yangsan Hospital
More Information
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Responsible Party: Kim Hee Young, Assistant professor for fund, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT05907525    
Other Study ID Numbers: 05-2023-133
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kim Hee Young, Pusan National University Yangsan Hospital:
remimazolam
one-lung ventilation
arterial oxygenation
 hypoxic pulmonary vasoconstriction
sevoflurane
thoracic surgery
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics