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

NCT05907525 | Completed

• 1 other identifier: 05-2023-133
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

One-Lung Ventilation; Thoracic Surgery, Video-Assisted; Remimazolam

Keywords

remimazolam; one-lung ventilation; arterial oxygenation; hypoxic pulmonary vasoconstriction; sevoflurane; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• PaO2 after 30 minutes of OLV (T2)

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

  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 (6)

• Changes of PaO2

  During 60 minutes of OLV

• Changes of PaCO2

  During 60 minutes of OLV

• Changes of P/F ratio

  During 60 minutes of OLV

• The lowest PaO2

  During 60 minutes of OLV

• Changes of ORI

  During 60 minutes of OLV

Other Outcomes (2)

• cardiac output

  During 60 minutes of OLV

• airway pressure

  During 60 minutes of OLV

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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

Sevoflurane group

ACTIVE COMPARATOR

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

Interventions

Remimazolam DRUG

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.

Also known as: Byfavo

Remimazolam group

1% propofol DRUG

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.

Also known as: Fresofol MCT 1%

Sevoflurane group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing video-assisted thoracoscopic surgery
• years of age or older, less than 80 years old
• The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status

You may not qualify if:

• 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%

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Please Select, 50612, South Korea

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hee Young Kim, MD. PhD

  Pusan National University Yangsan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor for fund

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 18, 2023
• Study Start: June 29, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)