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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
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.
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.
Shuang Ho Hospital, Taipei Medical University
Taipei, Taiwan
Time to spontaneous eye opening
The interval from the cessation of anesthetics to spontaneous eye opening
Time frame: At the end of surgery
Rate of in-hospital postoperative pulmonary complications
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 frame: Within 30 days after surgery
Time to tracheal extubation
The interval from the cessation of anesthetics to tracheal extubation
Time frame: At the end of surgery
Time to orientation in time and place
The interval from the cessation of anesthetics to orientation in time and place
Time frame: At the end of surgery
Time to leave operating room
The interval from the cessation of anesthetics to leave operating room
Time frame: At the end of surgery
Rate of emergence agitation
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.
Time frame: During the recovery from anesthesia
Rate of postoperative delirium
Events of delirium will be evaluated using the Confusion Assessment Method at the postanesthetic care unit.
Time frame: 30 minutes after tracheal extubation
Rate of intraoperative recall or awareness
As titled
Time frame: One day after surgery
Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)
The relative change of PaO2/FiO2 values after induction of anesthesia and at the end of surgery
Time frame: After induction of anesthesia and at the end of surgery
Rate of cardiac complications
Myocardial infarction diagnosed by electrocardiogram and troponin T serum concentration; newly developed atrial fibrillation.
Time frame: Within 30 days after surgery
Rate of hypotensive episodes
This is defined as a decrease in mean arterial pressure \> 20% for more than 15 min requiring vasopressors.
Time frame: Within 30 days after surgery
Rate of newly developed stroke
This will be based on the finding of imaging tests.
Time frame: Within 30 days after surgery
Length of hospital stay
As titled
Time frame: Within 30 days after surgery
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