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

NCT ID: NCT04414228

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2021-11-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

M-Entropy guidance of anesthesia depth

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

ProAQT in guiding goal-directed hemodynamic therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

YingHsuanTai

Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying-Hsuan Tai, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Shuang Ho Hospital, Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

N202004045

Identifier Type: -

Identifier Source: org_study_id