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Completed

NCT Number: NCT04414228

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

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.

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Key information

Conditions

Anesthesia Hemodynamic Instability Postoperative Respiratory Complication

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shuang Ho Hospital, Taipei Medical University

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M-Entropy guidance of anesthesia depth

Device

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.

ProAQT in guiding goal-directed hemodynamic therapy

Device

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.

Primary outcomes

  1. Time to spontaneous eye opening

    Time frame: At the end of surgery

    The interval from the cessation of anesthetics to spontaneous eye opening

  2. Rate of in-hospital postoperative pulmonary complications

    Time frame: 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 outcomes

  1. Time to tracheal extubation

    Time frame: At the end of surgery

    The interval from the cessation of anesthetics to tracheal extubation

  2. Time to orientation in time and place

    Time frame: At the end of surgery

    The interval from the cessation of anesthetics to orientation in time and place

  3. Time to leave operating room

    Time frame: At the end of surgery

    The interval from the cessation of anesthetics to leave operating room

  4. Rate of emergence agitation

    Time frame: 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.

  5. Rate of postoperative delirium

    Time frame: 30 minutes after tracheal extubation

    Events of delirium will be evaluated using the Confusion Assessment Method at the postanesthetic care unit.

  6. Rate of intraoperative recall or awareness

    Time frame: One day after surgery

    As titled

  7. Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)

    Time frame: 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

  8. Rate of cardiac complications

    Time frame: Within 30 days after surgery

    Myocardial infarction diagnosed by electrocardiogram and troponin T serum concentration; newly developed atrial fibrillation.

  9. Rate of hypotensive episodes

    Time frame: Within 30 days after surgery

    This is defined as a decrease in mean arterial pressure > 20% for more than 15 min requiring vasopressors.

  10. Rate of newly developed stroke

    Time frame: Within 30 days after surgery

    This will be based on the finding of imaging tests.

  11. Length of hospital stay

    Time frame: Within 30 days after surgery

    As titled

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

An Investigation of the Impact of Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring on the Clinical Outcomes of Patients Undergoing Thoracic Surgery: A Factorial Parallel Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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