Anesthesia, GeneralNCT03807271
Calculated and Graphically Produced Depth of Anesthesia
A study testing Calculated and graphically produced depth of anesthesia (Smart Pilot® View) in people with Anesthesia, General, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jan 2019to 13 Nov 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Standard premedication
- General anesthesia, total intravenous anesthesia
Who cannot join
- Alcoholics
- BMI 35 or higher
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model
There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles.
Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.
New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.
- Conditions
- Anesthesia, General
- Being tested
- Calculated and graphically produced depth of anesthesia (Smart Pilot® View)
- Keywords
- Anesthesia, Methods, Anesthesia, Analysis, Patient Safety, Anesthetics/administration and dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculated and graphically produced depth of anesthesia (Smart Pilot® View)Device
Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
| Study group | Role | What they receive |
|---|---|---|
| Smart Pilot(R) View | Experimental | Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia. Receives: Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View) |
| Standard | No intervention | Anesthesia provided by standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP)
Measured: Maximum 5 hours
Secondary outcomes (12)
Heart Rate (HR)
Measured: Maximum 5 hours
Bispectral Index (BIS)
Measured: Maximum 5 hours
Total dosis of Propofol in milligrams
Measured: Maximum 5 hours
Total dosis of Remifentanil in micrograms
Measured: Maximum 5 hours
Total dosis of Ephedrine in milligrams
Measured: Maximum 5 hours
Total dosis of Phenylephrine in micrograms
Measured: Maximum 5 hours
Total dosis of Atropine in micrograms
Measured: Maximum 5 hours
Total dosis of Norepinephrine in micrograms
Measured: Maximum 5 hours
Duration of surgery in minutes
Measured: Maximum 5 hours
Duration of anesthesia in minutes
Measured: Maximum 5 hours
Time until extubation in minutes
Measured: Maximum 5 hours
Duration of stay in postoperative ward in minutes
Measured: Maximum 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start14 Jan 2019
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Heidi Vifladt, MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807271
- Sponsor's protocol ID
- 2018/2176
- Status last verified
- Dec 2019
- First submitted
- 9 Jan 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strand H, Elshaug AC, Bernersen O, Ballangrud R. Effectiveness of the advisory display SmartPilot(R) view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial. BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.
PubMed 35227197
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Anaesthesia Using Pharmacokinetic/Pharmacodynamic Model
- ClinicalTrials.gov ID
- NCT03807271
- Acronym / sponsor ID
- 2018/2176
- Conditions
- Anesthesia, General
- Keywords
- Anesthesia, Methods, Anesthesia, Analysis, Patient Safety, Anesthetics/administration and dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 16 Jan 2019 (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.
There are studies that suggest that unsatisfying levels of anesthesia can cause peri- and postoperative complications in the patient undergoing surgery. Having a unnecessary "deep" anesthesia level can be harmful, causing acute renal failure, injure to myocard, cause delirium and increase the mortality rate. Being too "light", on the other hand, can make the patient experience awareness when muscle relaxant is used. This can lead to serious psychological struggles.
Evaluating the depth of anesthesia is the most important task of the anesthesia team, but can be difficult because clinical signs depend on many factors. In addition to clinical evaluation, EEG is commonly used for interpreting the level of anesthesia in todays practice. Unfortunately, this method is not always accurate and has a delay.
New devices are now developed to calculate the anesthesia level based on the drugs given. The level is simultaneously presented graphically on screen. The purpose of this study is to investigate and compare clinical parameters within patients undergoing general anesthesia, with and without the use of such devices. Hemodynamic stability, less use of adrenergics, higher EEG-levels, a more rapid wake-up and shorter time in post operative care can indicate a more precise level of anesthesia, hence, promote patient safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Pilot(R) View | Experimental | Device: Calculated and graphically produced depth of anesthesia (Smart Pilot® View)Anesthesia provided by standard procedure, additionally guided by Smart Pilot(R) View, a device with calculated and graphically produced depth of anesthesia. |
| Standard | No intervention | –Anesthesia provided by standard procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-3
- Standard premedication
- General anesthesia, total intravenous anesthesia
Key exclusion criteria (3 listed)
- Alcoholics
- BMI 35 or higher
- Unable to give consent
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 |
|---|---|---|
| Calculated and graphically produced depth of anesthesia (Smart Pilot® View)Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly. | Device | Smart Pilot(R) View |
Primary outcome
Mean Arterial Pressure (MAP)
Time frame: Maximum 5 hours
12 secondary outcomes
Heart Rate (HR)
Time frame: Maximum 5 hours
Bispectral Index (BIS)
Time frame: Maximum 5 hours
Total dosis of Propofol in milligrams
Time frame: Maximum 5 hours
Total dosis of Remifentanil in micrograms
Time frame: Maximum 5 hours
Total dosis of Ephedrine in milligrams
Time frame: Maximum 5 hours
Total dosis of Phenylephrine in micrograms
Time frame: Maximum 5 hours
Total dosis of Atropine in micrograms
Time frame: Maximum 5 hours
Total dosis of Norepinephrine in micrograms
Time frame: Maximum 5 hours
Duration of surgery in minutes
Time frame: Maximum 5 hours
Duration of anesthesia in minutes
Time frame: Maximum 5 hours
Time until extubation in minutes
Time frame: Maximum 5 hours
Duration of stay in postoperative ward in minutes
Time frame: Maximum 2 days
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 11 Dec 2019.
- Derived from this study: PubMed 35227197Strand H, Elshaug AC, Bernersen O, Ballangrud R. Effectiveness of the advisory display SmartPilot(R) view in the assessment of anesthetic depth in low risk gynecological surgery patients: a randomized controlled trial. BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.
- Individual participant dataSharing planned: No
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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.
Heidi Vifladt, MD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calculated and graphically produced depth of anesthesia (Smart Pilot® View) in people with Anesthesia, General, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 3 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 11 Dec 2019. 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 Norway. 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?
Mean Arterial Pressure (MAP) (time frame: Maximum 5 hours). 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 NCT03807271, which also lists 1 linked publication.
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 11 Dec 2019.