Anesthesia AwarenessClosedloop TCINCT03773588
Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol
A study of Anesthesia Awareness, run by KVG Medical College and Hospital at 1 site in India.
Trial summary
Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia Awareness
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 10 Oct 2018to 15 Jan 2019
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Scheduled for noncardiac surgery elective low-risk or intermediate risk. -Expected surgery time greater than 1 hour
- Procedure requiring general anesthesia
- Classification of the American Society of Anesthesiologists (ASA) as I,II, lll
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.
India1 site, 1 recruiting
- Recruiting
Subbaih institute of medical sciences
Shimoga, Karnataka
Shivakumar M Channabasappa, MD, 9620306582, drshivakumar.m.c@gmail.com
About this study
Official title: Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.
Read the detailed description
Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total intravenous anesthesia is more effective to maintain depth of anesthesia compared with target controlled infusion with open systems, 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 hypnotic is better than the controlled algorithm based pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of Anesthesia depth.
The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI for administration of intravenous anesthesia using adequacy of anesthesia monitoring to maintain a depth of anesthesia compared to an open loop system TCI.
- Conditions
- Anesthesia Awareness
- Being tested
- Closed-Loop propofol Target controlled infusion by Entropy and SPI, Open-loop propofol target controlled infusion
- Keywords
- Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Loop propofol Target controlled infusion by Entropy and SPIDevice
Also called Closed-loop propofol Target controlled infusion
Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
Open-loop propofol target controlled infusionDevice
Also called Open-loop propofol TCI
Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop propofol Target control infusion | Active comparator | Closed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI Receives: Device: Closed-Loop propofol Target controlled infusion by Entropy and SPI |
| Open-loop propofol target control infusion | Active comparator | Open-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm Receives: Device: Open-loop propofol target controlled infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of anesthesia
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 Spatial entropy in the range of 40 - 60 during a surgery.
Measured: 1 day
Time taken for recovery from Anesthesia
Total time taken for recovery after stopping of infusion
Measured: 1 day
Secondary outcomes (2)
Total consumption of propofol
Total consumption of propofol during surgery
Measured: 1 day
Number of hypotension events
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start10 Oct 2018
- Primary completion10 Jan 2019 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia AwarenessStudies 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
- Sequential
- Model description
- Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KVG Medical College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivakumar M C, MD, KVG Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773588
- Sponsor's protocol ID
- SMCH01
- Acronym
- Closedloop TCI
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion (TCI) Total Intravenous Anaesthesia (TIVA) With Propofol
- ClinicalTrials.gov ID
- NCT03773588
- Acronym / sponsor ID
- Closedloop TCI / SMCH01
- Conditions
- Anesthesia Awareness
- Keywords
- Closed loop, Entropy, Surgical pleth index, Adequacy of Anesthesia, Target controlled infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KVG Medical College and HospitalUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Jan 2019 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 12 Dec 2018 (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.
Closed-loop infusion system for target controlled infusion of propofol by using TCI pump designed by BD Technology. (Germany) guided with entropy and surgical pleth index (GE) will not only prevent awareness from Anesthesia but also optimise the dose anesthetic agents based on feedback from adequacy of Anesthesia monitoring. Which not only reduces Anesthesia agents but also enhances recovery from Anesthesia. Innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of Entropy.In this study we performed a randomized, controlled, study to compare closed-loop control and open-loop control of propofol by using the Entropy and SPI guided closed-loop infusion system.
Detailed description
Monitoring of Adequacy of Anesthesia using Entropy and Surgical pleth index to guide total intravenous anesthesia is more effective to maintain depth of anesthesia compared with target controlled infusion with open systems, 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 hypnotic is better than the controlled algorithm based pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain anesthetic depth. Thus, a system was designed for intravenous anesthesia in closed loop for propofol as hypnotic based on neuromonitoring with Entropy and surgical pleth index as adequacy of Anesthesia depth.
The purpose of this study is to determine the therapeutic effectiveness of a closed loop TCI for administration of intravenous anesthesia using adequacy of anesthesia monitoring to maintain a depth of anesthesia compared to an open loop system TCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Device: Closed-Loop propofol TCI with Entropy and SPI Device: Open-Loop propofol by Target Controlled Infusion Drug: propofol
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop propofol Target control infusion | Active comparator | Device: Closed-Loop propofol Target controlled infusion by Entropy and SPIClosed loop target controlled infusion(TCI) TIVA with propofol using BD TCI pumps guided by entropy and SPI |
| Open-loop propofol target control infusion | Active comparator | Device: Open-loop propofol target controlled infusionOpen-loop target controlled infusion of propofol using BD TCI pumps based on Schnider effect site algorithm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years
- Scheduled for noncardiac surgery elective low-risk or intermediate risk. -Expected surgery time greater than 1 hour
- Procedure requiring general anesthesia
- Classification of the American Society of Anesthesiologists (ASA) as I,II, lll
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 Target controlled infusion by Entropy and SPIAlso: Closed-loop propofol Target controlled infusionClosed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index | Device | Closed-Loop propofol Target control infusion |
| Open-loop propofol target controlled infusionAlso: Open-loop propofol TCIPropofol target controlled infusion using Schnider algorithm to determine effect site concentration | Device | Open-loop propofol target control infusion |
Primary outcome
Adequacy of anesthesia
Time frame: 1 day
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 Spatial entropy in the range of 40 - 60 during a surgery.
Time taken for recovery from Anesthesia
Time frame: 1 day
Total time taken for recovery after stopping of infusion
2 secondary outcomes
Total consumption of propofol
Time frame: 1 day
Number of hypotension events
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia Awareness
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
RecruitingObservational study
Evaluation of Intraoperative Awareness and Its Correlation With Processed EEG Biomarkers During Laparoscopic Surgery
Intraoperative Awareness, Intraoperative Responsiveness During General Anesthesia
Recruiting
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Surgery-Complications, Anesthesia Complication
RecruitingObservational study
Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively
Anxiety, Anesthesia Awareness
Not yet recruitingObservational study
Deep Learning Framework for Continuous Depth of Anesthesia Forecasting
BIS, BIS-EEG
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anesthesia Awareness, run by KVG Medical College and Hospital at 1 site in India.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of anesthesia (time frame: 1 day). 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 12 Dec 2018.