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

Anesthesia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414228
• Other study ID #: N202004045
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: November 18, 2021

Study information

• Verified date: May 2022
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamic Instability
• Postoperative Respiratory Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital, Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to spontaneous eye opening	The interval from the cessation of anesthetics to spontaneous eye opening	At the end of surgery
Primary	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	Time to tracheal extubation	The interval from the cessation of anesthetics to tracheal extubation	At the end of surgery
Secondary	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
Secondary	Time to leave operating room	The interval from the cessation of anesthetics to leave operating room	At the end of surgery
Secondary	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
Secondary	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
Secondary	Rate of intraoperative recall or awareness	As titled	One day after surgery
Secondary	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
Secondary	Rate of cardiac complications	Myocardial infarction diagnosed by electrocardiogram and troponin T serum concentration; newly developed atrial fibrillation.	Within 30 days after surgery
Secondary	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
Secondary	Rate of newly developed stroke	This will be based on the finding of imaging tests.	Within 30 days after surgery
Secondary	Length of hospital stay	As titled	Within 30 days after surgery