Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring in Thoracic Surgery

Taipei Medical University

Status: Completed

Conditions: Hemodynamic Instability; Postoperative Respiratory Complication; Anesthesia

Treatments: Device: M-Entropy guidance of anesthesia depth; Device: ProAQT in guiding goal-directed hemodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04414228

N202004045

Details and patient eligibility

About

Patients undergoing thoracotomy in thoracic surgery are prone to have complications of delayed recovery from general anesthesia and perioperative instable hemodynamics due to the relatively invasive procedures and patient's underlying morbidity. Therefore, intraoperative monitoring and corresponding management are of great importance to prevent relevant complications in thoracic surgery. This study aims to investigate the clinical benefits of two intraoperative monitoring techniques in patients undergoing thoracotomy surgery, including depth of anesthesia and minimally invasive cardiac output monitoring. First, M-Entropy system will be used to measure the depth of anesthesia and be evaluated regarding the effect of spectral entropy guidance on postoperative recovery. Second, we will apply ProAQT device in guiding goal-directed hemodynamic therapy and assess its impact on occurrence of postoperative pulmonary complications and recovery. In this study, we will conduct a factorial parallel randomized controlled trial and use the method of stratified randomization to evaluate both two monitoring technologies in the same patient group. The results of this study will provide important evidence and clinical implication for precision anesthesia and enhanced recovery after surgery (ERAS) protocol in thoracic surgery.

Enrollment: 76 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.

Exclusion criteria

• Age < 20 years
• Pregnancy
• End-stage renal disease
• Emergency surgery
• Presence of circulatory shock needing vasoactive drugs before surgery
• Any diagnosis of aortic diseases
• Cerebral vascular diseases or trauma
• High-degree cardiac arrythmia (e.g. atrial fibrillation)
• Uses of cardiac pacemaker or automated implantable cardioverter defibrillator
• New York Heart Association functional classification 4
• Long-term use of psychiatric medications
• Intraoperative blood loss > 1 L
• Intraoperative blood transfusion
• Planned or unanticipated transferal to ICU for postoperative mechanical ventilation
• Patient refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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76 participants in 2 patient groups

M-Entropy guidance of anesthesia depth

Active Comparator group

Description:

In the M-Entropy group, dosage of volatile anesthetics will be adjusted to achieve the response and state entropy values between 40 and 60 from the start of anesthesia to the end of surgery. In the control group, dosage of volatile anesthetics will be titrated according to clinical judgment.

Treatment:

Device: M-Entropy guidance of anesthesia depth

ProAQT in guiding goal-directed hemodynamic therapy

Active Comparator group

Description:

Subjects randomized to the GDT group will be managed according to the ERAS algorithm utilizing ProAQT variables (mean arterial pressure, stroke volume variation and cardiac index) If stroke volume variation is ≥ 10%, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is \< 10%. If mean arterial pressure is \< 70 mmHg and/or cardiac index \< 2.5 l·min-1·m-2 despite the stroke volume variation of \< 10% following fluid challenge, single or consecutive boluses of ephedrine 4 mg and/or continuous intravenous infusion of norepinephrine 2-10 μg·min-1 will be administered.

Treatment:

Device: ProAQT in guiding goal-directed hemodynamic therapy