General Anesthetic Drug OverdosePhase 1NCT02886806
Fully Automated Anesthesia, Analgesia and Fluid Management
A Phase 1 study testing BIS XP, Covidien, Ireland and EV-1000 TM, Edwards Lifesciences, Irvine, California, USA in people with General Anesthetic Drug Overdose and Adverse Effect of Intravenous Anesthetics, Sequela, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- General Anesthetic Drug Overdose, Adverse Effect of Intravenous Anesthetics, Sequela, Complication of Anesthesia
- What is being tested?
- BIS XP, Covidien, Ireland and EV-1000 TM, Edwards Lifesciences, Irvine, California, USA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to Jan 2017
- Phase
- Phase 1
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for high risk vascular surgery
- Patients American Society Anesthesiologist classification: 3 or 4
Who cannot join
- age less than 18 years,
- patients with arrhythmias like atrial fibrillation
- allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
- pregnant woman
- combined general and regional anesthesia,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery
Read the detailed description
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery.
All patients will receive total intravenous anesthesia in target controlled infusion mode using the population pharmacokinetic sets of Schnider for propofol and Minto for remifentanil to target the effect-site concentration. Infusion Toolbox 95 version 4.11 software (Free University of Brussels, Brussels, Belgium) implemented in a personal computer serving as a platform for: calculating effect-site concentrations of propofol and remifentanil; displaying effect-site concentration estimates in real time; providing a user interface that permits entry of patients' demographic data (sex, age, weight, and height) and modifications to target concentrations; controlling the propofol and remifentanil infusion pumps (Alaris Medical, Hampshire, United Kingdom); and recording calculated effect-site drug concentrations.
All patients will receive a baseline crystalloid infusion (PlasmaLyte, Baxter, Belgium) delivered by a pump at a rate of 3 mL/ kg/h (Fresenius Kabi, Belgium). Additional fluid was given using a goal-directed fluid therapy protocol guided by the cardiac output monitor (EV-1000; Edwards Lifesciences) and consisted of 100 mL boluses (Voluven, Fresenius Kabi, Germany) delivered by our PCLS (Learning Intravenous Resuscitator [LIR]). For fluid output, a Q-Core Sapphire Multi-Therapy Infusion Pump (Q-Core, Israel) was controlled by the LIR using software provided by Q-Core via a serial connection (Commands Server R.01). If hypotension occurred (defined as mean arterial pressure <20% of baseline blood pressure) and no fluid is delivered by the LIR, it will be treated by the anesthesiologist using a vasopressor drug.
In this pilot study, each closed loop also will operate independently, guided only by its own respective inputs (BIS for the propofol; SV and SVV for the fluid boluses).
The investigators will also measure analgesia using the PhysioDoloris monitoring device (MDoloris Medical Systems, Lille, France).
- Conditions
- General Anesthetic Drug Overdose, Adverse Effect of Intravenous Anesthetics, Sequela, Complication of Anesthesia, Drug Delivery System Malfunction, Hemodynamic Instability, Underdosing of Other General Anesthetics
- Being tested
- BIS XP, Covidien, Ireland, EV-1000 TM, Edwards Lifesciences, Irvine, California, USA
- Keywords
- closed loop, remifentanil, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS XP, Covidien, IrelandOther
Also called bispectral index
Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
EV-1000 TM, Edwards Lifesciences, Irvine, California, USAOther
Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA
| Study group | Role | What they receive |
|---|---|---|
| high risk vascular surgery | Experimental | Patients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management Receives: Other: BIS XP, Covidien, Ireland; Other: EV-1000 TM, Edwards Lifesciences, Irvine, California, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of adequate anesthesia defined as a BIS between between 40 and 60, a SVV < 13% and/or cardiac index > 2.5 litre/min/m² for more/equal of 85% of the surgical time
Measured: at time of surgery
Secondary outcomes (12)
Drug consumption: remifentanil dose
Measured: at time of surgery
Drug consumption: propofol dose
Measured: at time of surgery
amount of fluid given
Measured: at time of surgery
number of automatic modifications of the propofol and remifentanil concentrations
Measured: at time of surgery
number of patients movements
Measured: at time of surgery
number of hemodynamic abnormalities requiring treatment
Measured: at time of surgery
time to tracheal extubation
Measured: at time of surgery
intraoperative awareness
Measured: postoperative day 1 or 2
Occurrence of burst suppression
Measured: at time of surgery
Need for anesthetist interventions over the system during the surgery
Measured: at time of surgery
performance of the closed-loop system
Measured: at time of surgery
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug OverdoseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Foch
- Responsible party
- Principal investigator, Luc Barvais, Erasme University Hospital
- Investigators
- Luc Barvais, MD PhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886806
- Sponsor's protocol ID
- P2016/328
- Status last verified
- Jan 2017
- First submitted
- 29 Aug 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Automated Anesthesia, Analgesia and Fluid Management Using Multiple Physiologic Closed-Loop Systems in High-Risk Vascular Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT02886806
- Acronym / sponsor ID
- P2016/328
- Conditions
- General Anesthetic Drug Overdose, Adverse Effect of Intravenous Anesthetics, Sequela, Complication of Anesthesia, Drug Delivery System Malfunction, Hemodynamic Instability, Underdosing of Other General Anesthetics
- Keywords
- closed loop, remifentanil, propofol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Hopital Foch
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery
Detailed description
Evaluate the feasibility and quality of automated anesthesia, analgesia and fluid management based on a combination of several physiological variables (bispectral index [BIS], stroke volume [SV], and stroke volume variation [SVV]) using 2 independent physiologic closed-loop systems (PCLS) in patients undergoing high risk vascular surgery.
All patients will receive total intravenous anesthesia in target controlled infusion mode using the population pharmacokinetic sets of Schnider for propofol and Minto for remifentanil to target the effect-site concentration. Infusion Toolbox 95 version 4.11 software (Free University of Brussels, Brussels, Belgium) implemented in a personal computer serving as a platform for: calculating effect-site concentrations of propofol and remifentanil; displaying effect-site concentration estimates in real time; providing a user interface that permits entry of patients' demographic data (sex, age, weight, and height) and modifications to target concentrations; controlling the propofol and remifentanil infusion pumps (Alaris Medical, Hampshire, United Kingdom); and recording calculated effect-site drug concentrations.
All patients will receive a baseline crystalloid infusion (PlasmaLyte, Baxter, Belgium) delivered by a pump at a rate of 3 mL/ kg/h (Fresenius Kabi, Belgium). Additional fluid was given using a goal-directed fluid therapy protocol guided by the cardiac output monitor (EV-1000; Edwards Lifesciences) and consisted of 100 mL boluses (Voluven, Fresenius Kabi, Germany) delivered by our PCLS (Learning Intravenous Resuscitator [LIR]). For fluid output, a Q-Core Sapphire Multi-Therapy Infusion Pump (Q-Core, Israel) was controlled by the LIR using software provided by Q-Core via a serial connection (Commands Server R.01). If hypotension occurred (defined as mean arterial pressure <20% of baseline blood pressure) and no fluid is delivered by the LIR, it will be treated by the anesthesiologist using a vasopressor drug.
In this pilot study, each closed loop also will operate independently, guided only by its own respective inputs (BIS for the propofol; SV and SVV for the fluid boluses).
The investigators will also measure analgesia using the PhysioDoloris monitoring device (MDoloris Medical Systems, Lille, France).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high risk vascular surgery | Experimental | Other: BIS XP, Covidien, Ireland, Other: EV-1000 TM, Edwards Lifesciences, Irvine, California, USAPatients scheduled for high risk vascular surgery under automated total closed loop intravenous anesthesia and fluid management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for high risk vascular surgery
- Patients American Society Anesthesiologist classification: 3 or 4
Key exclusion criteria (5 listed)
- age less than 18 years,
- patients with arrhythmias like atrial fibrillation
- allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
- pregnant woman
- combined general and regional anesthesia,
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 |
|---|---|---|
| BIS XP, Covidien, IrelandAlso: bispectral indexClosed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland | Other | high risk vascular surgery |
| EV-1000 TM, Edwards Lifesciences, Irvine, California, USAClosed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA | Other | high risk vascular surgery |
Primary outcome
The percentage of adequate anesthesia defined as a BIS between between 40 and 60, a SVV < 13% and/or cardiac index > 2.5 litre/min/m² for more/equal of 85% of the surgical time
Time frame: at time of surgery
12 secondary outcomes
Drug consumption: remifentanil dose
Time frame: at time of surgery
Drug consumption: propofol dose
Time frame: at time of surgery
amount of fluid given
Time frame: at time of surgery
number of automatic modifications of the propofol and remifentanil concentrations
Time frame: at time of surgery
number of patients movements
Time frame: at time of surgery
number of hemodynamic abnormalities requiring treatment
Time frame: at time of surgery
time to tracheal extubation
Time frame: at time of surgery
intraoperative awareness
Time frame: postoperative day 1 or 2
Occurrence of burst suppression
Time frame: at time of surgery
Need for anesthetist interventions over the system during the surgery
Time frame: at time of surgery
performance of the closed-loop system
Time frame: at time of surgery
Interactions between both closed-loop system during the intraoperative period especially during hypotension episodes
Time frame: at time of 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 4 Jan 2017.
- Individual participant dataSharing planned: Undecided
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.
Luc Barvais, MD PhD study director
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIS XP, Covidien, Ireland and EV-1000 TM, Edwards Lifesciences, Irvine, California, USA in people with General Anesthetic Drug Overdose and Adverse Effect of Intravenous Anesthetics, Sequela, run by Erasme University Hospital at 1 site in Belgium.
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 2 inclusion and 5 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 4 Jan 2017. 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The percentage of adequate anesthesia defined as a BIS between between 40 and 60, a SVV < 13% and/or cardiac index > 2.5 litre/min/m² for more/equal of 85% of the surgical time (time frame: at time of surgery). 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 4 Jan 2017.