Clinical trial NCT04414228: Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring in Thoracic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Hemodynamic Instability
Postoperative Respiratory Complication
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to spontaneous eye opening
timeFrame: At the end of surgery
measure: Rate of in-hospital postoperative pulmonary complications
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Time to tracheal extubation
timeFrame: At the end of surgery
measure: Time to orientation in time and place
timeFrame: At the end of surgery
measure: Time to leave operating room
timeFrame: At the end of surgery
measure: Rate of emergence agitation
timeFrame: During the recovery from anesthesia
measure: Rate of postoperative delirium
timeFrame: 30 minutes after tracheal extubation
measure: Rate of intraoperative recall or awareness
timeFrame: One day after surgery
measure: Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)
timeFrame: After induction of anesthesia and at the end of surgery
measure: Rate of cardiac complications
timeFrame: Within 30 days after surgery
measure: Rate of hypotensive episodes
timeFrame: Within 30 days after surgery
measure: Rate of newly developed stroke
timeFrame: Within 30 days after surgery
measure: Length of hospital stay
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shuang Ho Hospital, Taipei Medical University
Study officials:
affiliation: Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
name: Ying-Hsuan Tai, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: