AnesthesiaNCT04414228
Anesthetic Guidance of Depth of Anesthesia and Indirect Cardiac Output Monitoring in Thoracic Surgery
A study testing M-Entropy guidance of anesthesia depth and ProAQT in guiding goal-directed hemodynamic therapy in people with Anesthesia and Hemodynamic Instability, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia, Hemodynamic Instability, Postoperative Respiratory Complication
- What is being tested?
- M-Entropy guidance of anesthesia depth and ProAQT in guiding goal-directed hemodynamic therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2020to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
Who cannot join
- Age < 20 years
- Pregnancy
- End-stage renal disease
- Emergency surgery
- Presence of circulatory shock needing vasoactive drugs before surgery
- Any diagnosis of aortic diseases
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- M-Entropy guidance of anesthesia depth, ProAQT in guiding goal-directed hemodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-Entropy guidance of anesthesia depthDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ProAQT in guiding goal-directed hemodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to spontaneous eye opening
The interval from the cessation of anesthetics to spontaneous eye opening
Measured: 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.
Measured: Within 30 days after surgery
Secondary outcomes (11)
Time to tracheal extubation
The interval from the cessation of anesthetics to tracheal extubation
Measured: 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
Measured: At the end of surgery
Time to leave operating room
The interval from the cessation of anesthetics to leave operating room
Measured: 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.
Measured: 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.
Measured: 30 minutes after tracheal extubation
Rate of intraoperative recall or awareness
As titled
Measured: 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
Measured: 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.
Measured: 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.
Measured: Within 30 days after surgery
Rate of newly developed stroke
This will be based on the finding of imaging tests.
Measured: Within 30 days after surgery
Length of hospital stay
As titled
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start19 Jun 2020
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YingHsuanTai, Taipei Medical University Shuang Ho Hospital
- Investigators
- Ying-Hsuan Tai, M.D., M.Sc., Principal investigator, Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414228
- Sponsor's protocol ID
- N202004045
- Status last verified
- May 2022
- First submitted
- 29 May 2020
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04414228
- Acronym / sponsor ID
- N202004045
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-Entropy guidance of anesthesia depth | Active comparator | Device: M-Entropy guidance of anesthesia depthIn 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 | Active comparator | Device: ProAQT in guiding goal-directed hemodynamic therapySubjects 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing video-assisted thoracotomy for lung resection at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
Key exclusion criteria (15 listed)
- Age < 20 years
- Pregnancy
- End-stage renal disease
- Emergency surgery
- Presence of circulatory shock needing vasoactive drugs before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-Entropy guidance of anesthesia depthIn 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 therapyIf 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 |
Primary outcome
Time to spontaneous eye opening
Time frame: At the end of surgery
The interval from the cessation of anesthetics to spontaneous eye opening
Rate of in-hospital postoperative pulmonary complications
Time frame: Within 30 days after surgery
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.
11 secondary outcomes
Time to tracheal extubation
Time frame: At the end of surgery
Time to orientation in time and place
Time frame: At the end of surgery
Time to leave operating room
Time frame: At the end of surgery
Rate of emergence agitation
Time frame: During the recovery from anesthesia
Rate of postoperative delirium
Time frame: 30 minutes after tracheal extubation
Rate of intraoperative recall or awareness
Time frame: One day after surgery
Arterial partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)
Time frame: After induction of anesthesia and at the end of surgery
Rate of cardiac complications
Time frame: Within 30 days after surgery
Rate of hypotensive episodes
Time frame: Within 30 days after surgery
Rate of newly developed stroke
Time frame: Within 30 days after surgery
Length of hospital stay
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Hsuan Tai, M.D., M.Sc. principal investigator
Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-Entropy guidance of anesthesia depth and ProAQT in guiding goal-directed hemodynamic therapy in people with Anesthesia and Hemodynamic Instability, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to spontaneous eye opening (time frame: At the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.