Anesthesia, Hemodynamic Instability, Postoperative Respiratory Complication
Conditions
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.
Interventions
DEVICEM-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.
DEVICEProAQT in guiding goal-directed hemodynamic therapy
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.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to spontaneous eye opening | At the end of surgery | The interval from the cessation of anesthetics to spontaneous eye opening |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Time to tracheal extubation | At the end of surgery | The interval from the cessation of anesthetics to tracheal extubation |
| 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 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. |
| Rate of newly developed stroke | Within 30 days after surgery | This will be based on the finding of imaging tests. |
| Length of hospital stay | Within 30 days after surgery | As titled |
| 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 orientation in time and place | At the end of surgery | The interval from the cessation of anesthetics to orientation in time and place |
Countries
Taiwan
Outcome results
None listed