Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring in Thoracic Surgery
- Conditions
- AnesthesiaHemodynamic InstabilityPostoperative Respiratory Complication
- Interventions
- Device: ProAQT in guiding goal-directed hemodynamic therapyDevice: M-Entropy guidance of anesthesia depth
- Registration Number
- NCT04414228
- Lead Sponsor
- Taipei Medical University Shuang Ho Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description ProAQT in guiding goal-directed hemodynamic therapy ProAQT in guiding goal-directed hemodynamic therapy 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. M-Entropy guidance of anesthesia depth M-Entropy guidance of anesthesia depth 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.
- Primary Outcome Measures
Name Time Method Rate of in-hospital postoperative pulmonary complications Within 30 days after surgery This includes atelectasis, pleural effusion, pneumonia, empyema, pulmonary embolism, re-operation, and respiratory failure. The diagnosis of atelectasis and pleural effusion will be made based on routinely performed chest radiographs on postoperative days 1 and 3. Pneumonia will be diagnosed if a patient presents with fever, leukocytosis and new infiltrates on chest radiography. Pleural empyema and pulmonary embolism will be confirmed by spiral computed tomography scan. Respiratory failure is defined as described in the protocol.
Time to spontaneous eye opening At the end of surgery The interval from the cessation of anesthetics to spontaneous eye opening
- Secondary Outcome Measures
Name Time Method Time to tracheal extubation At the end of surgery The interval from the cessation of anesthetics to tracheal extubation
Time to orientation in time and place At the end of surgery The interval from the cessation of anesthetics to orientation in time and place
Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) After induction of anesthesia and at the end of surgery The relative change of PaO2/FiO2 values after induction of anesthesia and at the end of surgery
Time to leave operating room At the end of surgery The interval from the cessation of anesthetics to leave operating room
Rate of emergence agitation During the recovery from anesthesia Richmond Agitation-Sedation Scale will be used to evaluate the level of agitation and sedation promptly after extubation. This is defined as +4 combative, +3 very agitated, +2 agitated, +1 restless, 0 alert and calm, -1 drowsy, -2 light sedation, -3 moderate sedation, -4 deep sedation, and -5 unarousable.
Rate of postoperative delirium 30 minutes after tracheal extubation Events of delirium will be evaluated using the Confusion Assessment Method at the postanesthetic care unit.
Rate of intraoperative recall or awareness One day after surgery As titled
Rate of cardiac complications Within 30 days after surgery Myocardial infarction diagnosed by electrocardiogram and troponin T serum concentration; newly developed atrial fibrillation.
Rate of newly developed stroke Within 30 days after surgery This will be based on the finding of imaging tests.
Rate of hypotensive episodes Within 30 days after surgery This is defined as a decrease in mean arterial pressure \> 20% for more than 15 min requiring vasopressors.
Length of hospital stay Within 30 days after surgery As titled
Trial Locations
- Locations (1)
Shuang Ho Hospital, Taipei Medical University
🇨🇳Taipei, Taiwan