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

NCT05907525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-08-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Pusan National University Yangsan Hospital

    lead OTHER

Principal Investigators

  • Hee Young Kim, MD. PhD · Pusan National University Yangsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2024-04-15
Completion
2024-04-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907525 on ClinicalTrials.gov