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

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

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 Overview

• Status: Completed
• Conditions: Anesthesia; Hemodynamic Instability; Postoperative Respiratory Complication
• Intervention / Treatment: Device: M-Entropy guidance of anesthesia depth; Device: ProAQT in guiding goal-directed hemodynamic therapy

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Shuang Ho Hospital, Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Active Comparator: 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.	Device: ProAQT 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to spontaneous eye opening	The interval from the cessation of anesthetics to spontaneous eye opening	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.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to tracheal extubation	The interval from the cessation of anesthetics to tracheal extubation	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	At the end of surgery
Time to leave operating room	The interval from the cessation of anesthetics to leave operating room	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.	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.	30 minutes after tracheal extubation
Rate of intraoperative recall or awareness	As titled	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	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.	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.	Within 30 days after surgery
Rate of newly developed stroke	This will be based on the finding of imaging tests.	Within 30 days after surgery
Length of hospital stay	As titled	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Ying-Hsuan Tai, M.D., M.Sc., Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: N202004045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No