Anesthesia, GeneralPhase 3NCT02492282
Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System
A Phase 3 study testing Closed-Loop propofol and remifentanil system by Bispectral Index and propofol in people with Anesthesia, General and Anesthesia, Intravenous, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Closed loop system in intravenous anesthesia is more effective to maintain depth of anesthesia compared with manual system open, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General, Anesthesia, Intravenous
- What is being tested?
- Closed-Loop propofol and remifentanil system by Bispectral Index and propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Scheduled for noncardiac surgery elective low-risk or intermediate
- Expected surgery time greater than 1 hour
- Procedure requiring general anesthesia
- Classification of the American Society of Anesthesiologists (ASA) as I or II
Who cannot join
- Pregnant women
- Surgery scheduled urgent or emergency
- Personal history of allergy to eggs or any other part of propofol
- Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.
- Chronic use of benzodiazepines or antipsychotics
- A patient who does not consent to participate in the study prior to surgery or before randomization
- Need for anesthetic or analgesic blockade before surgery peripheral nerve
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Vicente Fundación
Medellín, Antioquia
About this study
Official title: Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System: a Randomized Controlled Trial.
Closed loop system in intravenous anesthesia is more effective to maintain depth of anesthesia compared with manual system open, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid is better than the controlled pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional closed system for remifentanil using hemodynamic variables and control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia compared to an open loop system TCI.
Read the detailed description
Total intravenous anesthesia (TIVA) is a technique in which general anesthesia is administered intravenously, exclusively, a combination of drugs in the absence of any anesthetic agent inhaled1. TIVA development is closely linked to that of perfusion systems; these make total intravenous anesthesia enjoy several advantages as high hemodynamic stability, anesthetic depth more balanced, rapid and predictable recovery, less medication administered, less pollution and lower toxicity , not only for the patient also for the surgical equipment 2,3, 4 .
Two methods for controlling drug administration can be distinguished: open-loop and closed-loop control.
Open loop control applies pharmacokinetics (PK)/pharmacodynamics (PD) models based on the estimation of concentration of the drug in certain parts of the body, without measuring these concentrations in real time. The inaccuracy resulting from the absolute concentration requires the clinician to manually titrate dosage and objective observation based on the concentration of the desired therapeutic effect. This titration requires high clinical experience and a process of intensive monitoring, which may divert the attention from critical situations which in turn leads to suboptimal therapy or even to put safety at risk patient5, 6.
The application of closed-loop systems for the administration of an anesthetic requires a perfect balance of all the basic components of a system of this type: a variable control of the specific therapeutic effect; a target value for this variable (usually called set point); an actuator control (in this case, the drug infusion pump); a system (in this case the patient); and control algorithm7. This system excludes the control anesthesiologist drug infusion which is determined by one or more clinical variables that directly reflect the relationship PK / PD which previously established the attending anesthesiologist. The controller automatically calculates the optimal rate of infusion based on the current value and the desired value of the controlling variable and previously established mathematical models.
With the appearance of electroencephalographic monitoring practice as a control variable, began to conduct studies to assess the cerebral effect of anesthetics. Linear model two compartments is used to describe the relationship of drug concentration and an adaptive controller and this system was used subsequently using EEG to study the interaction of opioid and propofol 8,9. After marketing bispectral index derived from the EEG, began to evaluate closed loop systems using the BIS technology in several studies concluding that such systems not only makes more predictable anesthetic depth, but provides greater intraoperative hemodynamic stability and early recovery of the sedative and hypnotic effects of propofol 10,11,12,13,14.
Closed loop system in intravenous anesthesia is more effective to maintain the depth of anesthesia compared with manual system open, it is unclear what the driver and the variables to achieve this goal be more physiological and accurately; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid is better than the controlled pharmacokinetic models and open loop system to maintain anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional closed system for remifentanil using hemodynamic variables and control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia compared to an open loop system TCI.
- Conditions
- Anesthesia, General, Anesthesia, Intravenous
- Being tested
- Closed-Loop propofol and remifentanil system by Bispectral Index, Open-Loop propofol and remifentanil by Target Controlled Infusion, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Loop propofol and remifentanil system by Bispectral IndexDevice
Open-Loop propofol and remifentanil by Target Controlled InfusionDevice
propofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop | Experimental | This group includes patients with randomization process be assigned to closed loop intravenous anesthesia; the system evaluates, feeds and acts according to the patient's bispectral index, excluding the anesthesiologist. This system use a variable control of specific therapeutic effect; a target value for this variable (set point); an actuator control (infusion pump), a system (patient) and a control algorithm. Receives: Device: Closed-Loop propofol and remifentanil system by Bispectral Index; Drug: propofol |
| Open-Loop | Active comparator | This group includes patients with the randomization process are assigned to open loop in which the application of anesthetics is exclusively with pharmacokinetic parameters using TCI and employs mathematical models drug. For propofol used Schneider model and Minto model for remifentanil based on effective site concentration. Changes will be made by the anesthesiologist according to his criteria, trying to keep the BIS range of 40 and 60. Receives: Device: Open-Loop propofol and remifentanil by Target Controlled Infusion; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in adequate anesthetic depth
Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Bispectral Index in the range of 40 - 60 during a surgery.
Measured: intraoperative
Secondary outcomes (9)
Proportion of patients with adequate anesthetic depth
Difference in the proportion of patients with adequate depth of anesthesia. Anesthetic depth is defined as appropriate when the percentage of time the patient spends in this range (BIS between 40 and 60) is greater than 80%.
Measured: intraoperative
Difference in technical performance drivers intravenous infusion
The performance will be determined using methods Varvel et al. Performance error (PE) is defined as the difference between the actual value and the target value. Median performance error (MDPE) and Error Performance Absolute Median (MDAPE) as measures of validity and accuracy, respectively. Wobble as a measure of variability in performance error.
Measured: intraoperative
Difference in the proportion of patients with adequate intraoperative analgesia
Difference in the proportion of patients with adequate analgesia intraoperative defined according to the values of "analgoscore", a scale for the measurement of intraoperative pain developed and validated by Hemmerling et al. It is based on measuring the averagely nociception determined mean arterial pressure and heart rate, which generates a numerical range between -9 and 9. A value between -3 and +3 represents excellent pain control; a value between -6 to -3 and +3 to +6 indicates good pain control;-6 To -9 and +9 +6 it indicates inadequate pain control. Adequate intraoperative analgesia is considered when the percentage of time the patient spends in the range of values between - 6 and +6 is greater than 80%.
Measured: intraoperative
Difference in the proportion of patients in which they have to perform manual modification of the drug infusion.
Any manual handling of the anesthesia system is considered one that performs different from the initial programming output.
Measured: intraoperative
Difference in the rate of change of an intravenous anesthetic technique to a technique based on halogenated.
Measured: intraoperative
Amount of anesthetic medications used during the anesthetic
Measured: intraoperative
Proportion of patients with haemodynamic instability.
Hemodynamic instability any of the following events are considered: Reduction of more than 20% of the basal MAP and HR increased more than 10% of baseline; Decreased heart rate less than 10% increase in MAP and more than 5%; Need for vasopressor support with bolus or continuous infusion of drugs alpha and / or beta-agonists; Parasympatholytic need.
Measured: intraoperative
Proportion of patients with intraoperative recall
Difference in the proportion of patients with intraoperative recall. Intraoperative recall will be measured with a validated scale as Michigan scale, which ranks intraoperative recall in 6 classes: Class 0, where there are no symptoms of memory; Class 1, isolated auditory perceptions; Class 2, tactile perceptions, such as surgical manipulation or endotracheal intubation; Class 3, Pain; Class 4, paralysis defined as the feeling of being unable to move, speak or breathe; Class 5, paralysis and pain. If any of these classes is associated with negative emotional impact (fear, anxiety, suffocation feeling of death, etc.) will be added to the letter D
Measured: 2 hours after surgery
Proportion of patients with awakening during anesthetic maintenance
It will be as any episode of patient movement during surgical painful stimulus including upper, lower or respiratory system (cough reflex to the presence of the endotracheal tube) extremities.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabian David Casas Arroyave, Universidad de Antioquia
- Investigators
- Fabian Casas, MD, Ms, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492282
- Sponsor's protocol ID
- TIVA-15517889
- Status last verified
- Jun 2016
- First submitted
- 4 Jul 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carregal A, Lorenzo A, Taboada JA, Barreiro JL. [Intraoperative control of mean arterial pressure and heart rate with alfentanyl with fuzzy logic]. Rev Esp Anestesiol Reanim. 2000 Mar;47(3):108-13. Spanish.
PubMed 10800361Ngan Kee WD, Khaw KS, Ng FF, Tam YH. Randomized comparison of closed-loop feedback computer-controlled with manual-controlled infusion of phenylephrine for maintaining arterial pressure during spinal anaesthesia for caesarean delivery. Br J Anaesth. 2013 Jan;110(1):59-65. doi: 10.1093/bja/aes339. Epub 2012 Sep 25.
PubMed 23015618Janda M, Simanski O, Bajorat J, Pohl B, Noeldge-Schomburg GF, Hofmockel R. Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*. Anaesthesia. 2011 Dec;66(12):1112-20. doi: 10.1111/j.1365-2044.2011.06875.x. Epub 2011 Sep 23.
PubMed 21950720Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.
PubMed 16672092Sakai T, Matsuki A, White PF, Giesecke AH. Use of an EEG-bispectral closed-loop delivery system for administering propofol. Acta Anaesthesiol Scand. 2000 Sep;44(8):1007-10. doi: 10.1034/j.1399-6576.2000.440819.x.
PubMed 10981581De Smet T, Struys MM, Neckebroek MM, Van den Hauwe K, Bonte S, Mortier EP. The accuracy and clinical feasibility of a new bayesian-based closed-loop control system for propofol administration using the bispectral index as a controlled variable. Anesth Analg. 2008 Oct;107(4):1200-10. doi: 10.1213/ane.0b013e31817bd1a6.
PubMed 18806028Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. doi: 10.1177/0310057X0703500306.
PubMed 17591128Struys MM, De Smet T, Versichelen LF, Van De Velde S, Van den Broecke R, Mortier EP. Comparison of closed-loop controlled administration of propofol using Bispectral Index as the controlled variable versus "standard practice" controlled administration. Anesthesiology. 2001 Jul;95(1):6-17. doi: 10.1097/00000542-200107000-00007.
PubMed 11465585Hemmerling TM, Arbeid E, Wehbe M, Cyr S, Taddei R, Zaouter C. Evaluation of a novel closed-loop total intravenous anaesthesia drug delivery system: a randomized controlled trial. Br J Anaesth. 2013 Jun;110(6):1031-9. doi: 10.1093/bja/aet001. Epub 2013 Feb 20.
PubMed 23427212
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02492282
- Acronym / sponsor ID
- TIVA-15517889
- Conditions
- Anesthesia, General, Anesthesia, Intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jul 2015 (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.
Closed loop system in intravenous anesthesia is more effective to maintain depth of anesthesia compared with manual system open, it is unclear what driver and variables to achieve this goal be more physiological; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid is better than the controlled pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional closed system for remifentanil using hemodynamic variables and control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia compared to an open loop system TCI.
Detailed description
Total intravenous anesthesia (TIVA) is a technique in which general anesthesia is administered intravenously, exclusively, a combination of drugs in the absence of any anesthetic agent inhaled1. TIVA development is closely linked to that of perfusion systems; these make total intravenous anesthesia enjoy several advantages as high hemodynamic stability, anesthetic depth more balanced, rapid and predictable recovery, less medication administered, less pollution and lower toxicity , not only for the patient also for the surgical equipment 2,3, 4 .
Two methods for controlling drug administration can be distinguished: open-loop and closed-loop control.
Open loop control applies pharmacokinetics (PK)/pharmacodynamics (PD) models based on the estimation of concentration of the drug in certain parts of the body, without measuring these concentrations in real time. The inaccuracy resulting from the absolute concentration requires the clinician to manually titrate dosage and objective observation based on the concentration of the desired therapeutic effect. This titration requires high clinical experience and a process of intensive monitoring, which may divert the attention from critical situations which in turn leads to suboptimal therapy or even to put safety at risk patient5, 6.
The application of closed-loop systems for the administration of an anesthetic requires a perfect balance of all the basic components of a system of this type: a variable control of the specific therapeutic effect; a target value for this variable (usually called set point); an actuator control (in this case, the drug infusion pump); a system (in this case the patient); and control algorithm7. This system excludes the control anesthesiologist drug infusion which is determined by one or more clinical variables that directly reflect the relationship PK / PD which previously established the attending anesthesiologist. The controller automatically calculates the optimal rate of infusion based on the current value and the desired value of the controlling variable and previously established mathematical models.
With the appearance of electroencephalographic monitoring practice as a control variable, began to conduct studies to assess the cerebral effect of anesthetics. Linear model two compartments is used to describe the relationship of drug concentration and an adaptive controller and this system was used subsequently using EEG to study the interaction of opioid and propofol 8,9. After marketing bispectral index derived from the EEG, began to evaluate closed loop systems using the BIS technology in several studies concluding that such systems not only makes more predictable anesthetic depth, but provides greater intraoperative hemodynamic stability and early recovery of the sedative and hypnotic effects of propofol 10,11,12,13,14.
Closed loop system in intravenous anesthesia is more effective to maintain the depth of anesthesia compared with manual system open, it is unclear what the driver and the variables to achieve this goal be more physiological and accurately; in the literature doesn´t exist studies showing that the closed-loop system for both hypnotic and opioid is better than the controlled pharmacokinetic models and open loop system to maintain anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was integrated an additional closed system for remifentanil using hemodynamic variables and control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia compared to an open loop system TCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop | Experimental | Device: Closed-Loop propofol and remifentanil system by Bispectral Index, Drug: propofolThis group includes patients with randomization process be assigned to closed loop intravenous anesthesia; the system evaluates, feeds and acts according to the patient's bispectral index, excluding the anesthesiologist. This system use a variable control of specific therapeutic effect; a target value for this variable (set point); an actuator control (infusion pump), a system (patient) and a control algorithm. |
| Open-Loop | Active comparator | Device: Open-Loop propofol and remifentanil by Target Controlled Infusion, Drug: propofolThis group includes patients with the randomization process are assigned to open loop in which the application of anesthetics is exclusively with pharmacokinetic parameters using TCI and employs mathematical models drug. For propofol used Schneider model and Minto model for remifentanil based on effective site concentration. Changes will be made by the anesthesiologist according to his criteria, trying to keep the BIS range of 40 and 60. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 18 years
- Scheduled for noncardiac surgery elective low-risk or intermediate
- Expected surgery time greater than 1 hour
- Procedure requiring general anesthesia
- Classification of the American Society of Anesthesiologists (ASA) as I or II
Key exclusion criteria (7 listed)
- Pregnant women
- Surgery scheduled urgent or emergency
- Personal history of allergy to eggs or any other part of propofol
- Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism.
- Chronic use of benzodiazepines or antipsychotics
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 |
|---|---|---|
| Closed-Loop propofol and remifentanil system by Bispectral Index | Device | Closed-Loop |
| Open-Loop propofol and remifentanil by Target Controlled Infusion | Device | Open-Loop |
| propofol | Drug | Closed-Loop, Open-Loop |
Primary outcome
Time in adequate anesthetic depth
Time frame: intraoperative
Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Bispectral Index in the range of 40 - 60 during a surgery.
9 secondary outcomes
Proportion of patients with adequate anesthetic depth
Time frame: intraoperative
Difference in technical performance drivers intravenous infusion
Time frame: intraoperative
Difference in the proportion of patients with adequate intraoperative analgesia
Time frame: intraoperative
Difference in the proportion of patients in which they have to perform manual modification of the drug infusion.
Time frame: intraoperative
Difference in the rate of change of an intravenous anesthetic technique to a technique based on halogenated.
Time frame: intraoperative
Amount of anesthetic medications used during the anesthetic
Time frame: intraoperative
Proportion of patients with haemodynamic instability.
Time frame: intraoperative
Proportion of patients with intraoperative recall
Time frame: 2 hours after surgery
Proportion of patients with awakening during anesthetic maintenance
Time frame: intraoperative
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 20 Jun 2016.
- Background: PubMed 10800361Carregal A, Lorenzo A, Taboada JA, Barreiro JL. [Intraoperative control of mean arterial pressure and heart rate with alfentanyl with fuzzy logic]. Rev Esp Anestesiol Reanim. 2000 Mar;47(3):108-13. Spanish.
- Results publication: PubMed 23015618Ngan Kee WD, Khaw KS, Ng FF, Tam YH. Randomized comparison of closed-loop feedback computer-controlled with manual-controlled infusion of phenylephrine for maintaining arterial pressure during spinal anaesthesia for caesarean delivery. Br J Anaesth. 2013 Jan;110(1):59-65. doi: 10.1093/bja/aes339. Epub 2012 Sep 25.
- Results publication: PubMed 21950720Janda M, Simanski O, Bajorat J, Pohl B, Noeldge-Schomburg GF, Hofmockel R. Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*. Anaesthesia. 2011 Dec;66(12):1112-20. doi: 10.1111/j.1365-2044.2011.06875.x. Epub 2011 Sep 23.
- Results publication: PubMed 16672092Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.
- Results publication: PubMed 10981581Sakai T, Matsuki A, White PF, Giesecke AH. Use of an EEG-bispectral closed-loop delivery system for administering propofol. Acta Anaesthesiol Scand. 2000 Sep;44(8):1007-10. doi: 10.1034/j.1399-6576.2000.440819.x.
- Results publication: PubMed 18806028De Smet T, Struys MM, Neckebroek MM, Van den Hauwe K, Bonte S, Mortier EP. The accuracy and clinical feasibility of a new bayesian-based closed-loop control system for propofol administration using the bispectral index as a controlled variable. Anesth Analg. 2008 Oct;107(4):1200-10. doi: 10.1213/ane.0b013e31817bd1a6.
- Results publication: PubMed 17591128Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. doi: 10.1177/0310057X0703500306.
- Results publication: PubMed 11465585Struys MM, De Smet T, Versichelen LF, Van De Velde S, Van den Broecke R, Mortier EP. Comparison of closed-loop controlled administration of propofol using Bispectral Index as the controlled variable versus "standard practice" controlled administration. Anesthesiology. 2001 Jul;95(1):6-17. doi: 10.1097/00000542-200107000-00007.
- Results publication: PubMed 23427212Hemmerling TM, Arbeid E, Wehbe M, Cyr S, Taddei R, Zaouter C. Evaluation of a novel closed-loop total intravenous anaesthesia drug delivery system: a randomized controlled trial. Br J Anaesth. 2013 Jun;110(6):1031-9. doi: 10.1093/bja/aet001. Epub 2013 Feb 20.
Related trials for Anesthesia, General
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
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
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
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Fabian Casas, MD, Ms principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Closed-Loop propofol and remifentanil system by Bispectral Index and propofol in people with Anesthesia, General and Anesthesia, Intravenous, run by Universidad de Antioquia at 1 site in Colombia.
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 5 inclusion and 7 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 20 Jun 2016. 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 Colombia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time in adequate anesthetic depth (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492282, which also lists 9 linked publications.
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 20 Jun 2016.