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

NCT04414228 | Completed

• 1 other identifier: N202004045
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Hemodynamic Instability; Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Time to tracheal extubation

  At the end of surgery

• Time to orientation in time and place

  At the end of surgery

• Time to leave operating room

  At the end of surgery

• Rate of emergence agitation

  During the recovery from anesthesia

• Rate of postoperative delirium

  30 minutes after tracheal extubation

Study Arms (2)

M-Entropy guidance of anesthesia depth

ACTIVE COMPARATOR

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

ProAQT in guiding goal-directed hemodynamic therapy

ACTIVE COMPARATOR

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

Interventions

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.

M-Entropy guidance of anesthesia depth

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.

ProAQT in guiding goal-directed hemodynamic therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital, Taipei Medical University

Taipei, Taiwan

Location

Study Officials

• Ying-Hsuan Tai, M.D., M.Sc.

  Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 19, 2020
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

TW (1)