Evaluation of Closed-loop Titration of the Intravenous Anesthetic Propofol, Sufentanil and Ketamine Guided by BIS Monitor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Time to discharge from PACU
Study Overview
Brief Summary
The purpose of this study is to compare a closed-loop intravenous anesthetic using Bispectral Index as a feedback loop and a controller based on reinforcement learning to titrate dose and intravenous anesthetic that is manually controlled or a standard volatile anesthetic agent titrated by the anesthesiologist to determine improvement in the following parameters as compared to controls: time to discharge from the Post Anesthesia Care Unit, post-operative nausea and vomiting, pain scores and sedation scores.
Detailed Description
Recent efforts have focused on the development of new software systems that are able to directly titrate anesthesia based on activity of the brain (EEG) as a feedback mechanism . Brain activity is used to measure the effect of anesthetic medications (anesthetic "depth"), which can vary from person to person despite being given the same amount of medication. There is a potential for new systems to considerably improve anesthetic control by using methods that are able to adapt to the constant input of brain activity. The purpose of this study is to compare a closed -loop intravenous anesthetic (TIVA) using BIS (Bispectral Index) as a feedback loop and a controller based on reinforcement learning to titrate dose and TIVA that is manually controlled or a standard volatile anesthetic agent titrated by the anesthesiologist.
Propofol is the most frequently applied hypnotic-anesthetic IV drug during anesthesia. In "open-loop" controlled propofol administration during anesthesia, initial dosing guidelines are based on the typical subject, without taking into account the large inter-individual variability. To manage this variability, most clinicians will start by giving a standard dose, observes the therapeutic effect and will adapt the dose regimen. Although, "open-loop" drug administration is clinically "standard-of-care", the efficiency of this decision process highly depends on the expertise of the clinician, is very time consuming and might result in a suboptimal therapy.
The study will be using patient with acute cholecystitis scheduled for laparoscopic cholecystectomy surgery and the inclusion/exclusion criteria is described in the appropriate sections. Potential subjects will be identified prior to their surgery based on meeting the inclusion/exclusion criteria. The subject will be approached in the inpatient unit or pre-operative holding area, a private area where curtains can be drawn to maintain privacy. This is a place where patients are routinely examined and consented prior to surgery.. The subject will be informed that participation or a lack of participation in the study does not influence their treatment in any way. The subject will be informed that if they give consent for participation in the study that they may withdraw consent at any time before performance of the study. This withdrawal of consent may be given to the investigator in oral or written form.
The Investigator will explain the study to the potential subject verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation, etc.), and allow the potential subject ample opportunity to ask questions. Following this verbal explanation, the potential subject will be provided with a written consent form and given at least one hour to consider whether or not to participate in the research. After allowing the potential subject time to read the consent form, an Investigator listed on the consent form will meet with the potential subject and answer any additional questions she/he may have.
The subject will have been pre randomized to a study arm (Permuted block randomisation via computer generated numbers) and will not be informed which study arm. The three study arms are RL-TIVA (experimental), Manual TIVA, and INH-Sevo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-65 years of age
- •Body mass index lower or equal to 40 m2/kg
- •Subjects must be able to comprehend spoken and written English or Spanish
Exclusion Criteria
- •Any type of psychiatric, neurological, or neuromuscular disorder
- •Thyroid disease
- •Alcohol consumption which exceeds 2 drinks per day and/or drug abuse.
- •Allergy to study medication proposal, soy or egg proteins
- •history of drug abuse
- •chronic or acute use of opioids, or other medications affecting the central nervous system
- •pregnancy
Arms & Interventions
RL-TIVA Group
Propofol, ketamine and sufentanil administration for a TIVA (total intravenous anesthetic) will be administered using a Harvard 33 syringe pump connected via a RS 232 interface to the study computer running the RL (Reinforcement Learning) control software. This software platform will collect real time vitals and BIS valises and steer the target controlled infusion pumps and the closed loop controllers. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Hypotension (Procedure)
RL-TIVA Group
Propofol, ketamine and sufentanil administration for a TIVA (total intravenous anesthetic) will be administered using a Harvard 33 syringe pump connected via a RS 232 interface to the study computer running the RL (Reinforcement Learning) control software. This software platform will collect real time vitals and BIS valises and steer the target controlled infusion pumps and the closed loop controllers. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Hypertension (Procedure)
RL-TIVA Group
Propofol, ketamine and sufentanil administration for a TIVA (total intravenous anesthetic) will be administered using a Harvard 33 syringe pump connected via a RS 232 interface to the study computer running the RL (Reinforcement Learning) control software. This software platform will collect real time vitals and BIS valises and steer the target controlled infusion pumps and the closed loop controllers. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Bradycardia (Procedure)
RL-TIVA Group
Propofol, ketamine and sufentanil administration for a TIVA (total intravenous anesthetic) will be administered using a Harvard 33 syringe pump connected via a RS 232 interface to the study computer running the RL (Reinforcement Learning) control software. This software platform will collect real time vitals and BIS valises and steer the target controlled infusion pumps and the closed loop controllers. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Tachycardia (Procedure)
Manual TIVA Group
Manually titrated TIVA (total intravenous anesethetic) with proposal, ketamine and sufentanil will be administered using an Alaris infusion pump titrated by the anesthesiologist based on blood pressure and heart-rate as is traditionally done and is standard of care with intravenous anesthetics. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Hypotension (Procedure)
Manual TIVA Group
Manually titrated TIVA (total intravenous anesethetic) with proposal, ketamine and sufentanil will be administered using an Alaris infusion pump titrated by the anesthesiologist based on blood pressure and heart-rate as is traditionally done and is standard of care with intravenous anesthetics. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Hypertension (Procedure)
Manual TIVA Group
Manually titrated TIVA (total intravenous anesethetic) with proposal, ketamine and sufentanil will be administered using an Alaris infusion pump titrated by the anesthesiologist based on blood pressure and heart-rate as is traditionally done and is standard of care with intravenous anesthetics. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Bradycardia (Procedure)
Manual TIVA Group
Manually titrated TIVA (total intravenous anesethetic) with proposal, ketamine and sufentanil will be administered using an Alaris infusion pump titrated by the anesthesiologist based on blood pressure and heart-rate as is traditionally done and is standard of care with intravenous anesthetics. The anesthesiologist will provide interventions based on protocol for TIVA - Hypotension, TIVA - Hypertension, TIVA - Bradycardia and TIVA - Tachycardia .
Intervention: TIVA - Tachycardia (Procedure)
Inhaled Sevofluorane Group
An inhaled anesthetic with Sevofluorane will be titrated between 0.8-1.5 MAC (minimum alveolar concentration) by the anesthesiologist based on heart rate and blood pressure which is standard of care for inhaled anesthetics. The anesthesiologist will provide interventions based on protocol for INH - Hypotension, INH - Hypertension, INH - Bradycardia and INH - Tachycardia .
Intervention: INH - Hypotension (Procedure)
Inhaled Sevofluorane Group
An inhaled anesthetic with Sevofluorane will be titrated between 0.8-1.5 MAC (minimum alveolar concentration) by the anesthesiologist based on heart rate and blood pressure which is standard of care for inhaled anesthetics. The anesthesiologist will provide interventions based on protocol for INH - Hypotension, INH - Hypertension, INH - Bradycardia and INH - Tachycardia .
Intervention: INH - Hypertension (Procedure)
Inhaled Sevofluorane Group
An inhaled anesthetic with Sevofluorane will be titrated between 0.8-1.5 MAC (minimum alveolar concentration) by the anesthesiologist based on heart rate and blood pressure which is standard of care for inhaled anesthetics. The anesthesiologist will provide interventions based on protocol for INH - Hypotension, INH - Hypertension, INH - Bradycardia and INH - Tachycardia .
Intervention: INH - Bradycardia (Procedure)
Inhaled Sevofluorane Group
An inhaled anesthetic with Sevofluorane will be titrated between 0.8-1.5 MAC (minimum alveolar concentration) by the anesthesiologist based on heart rate and blood pressure which is standard of care for inhaled anesthetics. The anesthesiologist will provide interventions based on protocol for INH - Hypotension, INH - Hypertension, INH - Bradycardia and INH - Tachycardia .
Intervention: INH - Tachycardia (Procedure)
Outcomes
Primary Outcomes
Time to discharge from PACU
Time Frame: < 2 hours post operatively
Secondary Outcomes
- Post operative Nausea and/or vomiting(< 2 hours post operatively)
- ALDRETE Sedation Score(< 2 hours post operatively)
- Visual Analog Scale Pain score(< 2 hours post operatively)
- Time to extubation(1-6 hours after the start of surgery)