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

P

Pusan National University Yangsan Hospital

Status

Completed

Conditions

Remimazolam
Thoracic Surgery, Video-Assisted
One-Lung Ventilation

Treatments

Drug: Remimazolam
Drug: 1% propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT05907525
05-2023-133

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No 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%

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

Remimazolam group
Experimental group
Description:
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.
Treatment:
Drug: Remimazolam
Sevoflurane group
Active Comparator group
Description:
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.
Treatment:
Drug: 1% propofol

Trial contacts and locations

1

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Central trial contact

Jung-Pil Yoon, MD

Data sourced from clinicaltrials.gov

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