SurgeryNCT01762332
Clinical Validation of Medasense Pain Response Index (PRI)
A study testing Base level of remifentanil effect side concentration: 2ng/ml, Base level of remifentanil effect side concentration: 4ng/ml and chronic beta-blocker treatment in people with Surgery and Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been changed to NoL (Nociception Level) Index. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Base level of remifentanil effect side concentration: 2ng/ml, Base level of remifentanil effect side concentration: 4ng/ml and chronic beta-blocker treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to 25 May 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3
- Elective surgery
Who cannot join
- Pregnancy or lactation
- History of severe cardiac arrhythmias
- Abuse of alcohol or illicit drugs
- History of mental retardation, dementia, psychiatric disorders
- Allergy to any of the drugs to be used during anesthesia and recovery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been changed to NoL (Nociception Level) Index.
The PRI is based on a non-linear combination of several pain-related physiological parameters into a one unique index (0-100).
Read more
In this study we aim to validate the performance of the PRI by:
- investigating the patient's PRI response to surgical painful stimuli under different levels of analgesia:
- Investigating patient's PRI response to surgical painful stimuli under two different levels of Remifentanil Target Control Infusion (TCI) rates.
- Investigating patient's PRI response to standardized painful stimulus (Tetanic stimulus) with and without opioids.
- investigating the effect of beta-blockers on PRI performance in patients taking chronic beta-blocker treatment.
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
Read the detailed description
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the Numeric Pain Scale (NPS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. As a consequence, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication, leading to possible complications and adverse reactions. A validated scoring system of subject's pain level, or as in the case of an anaesthetised patient, subject's nociception level, is therefore needed.
In this study the investigators intend to test and analyze the performances of Medasense pain response index, PRI, by comparing it with other standard pain related indicators (Heart Rate (HR), Heart Rate Variability (HRV), Skin Conductance, etc) before and after painful stimuli at different levels of analgesia. In addition, in order to reduce the variability between stimuli, a standardized stimulus (Tetanic ,30 sec, 100Hz, 60mA) will be given to all patients after sleep induction and before intubation, with and without administration of Fentanyl and the values of the PRI during these stimuli will be investigated.
- Being tested
- Base level of remifentanil effect side concentration: 2ng/ml, Base level of remifentanil effect side concentration: 4ng/ml, chronic beta-blocker treatment
- Keywords
- nociception, analgesia, intraoperative monitoring
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base level of remifentanil effect side concentration: 2ng/mlDrug
Also called Ultiva
constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
Base level of remifentanil effect side concentration: 4ng/mlDrug
Also called Ultiva
constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
chronic beta-blocker treatmentOther
Patients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group.
| Study group | Role | What they receive |
|---|---|---|
| Low opioid level | Active comparator | Base level of remifentanil effect side concentration: 2ng/ml Stopped recruitment (May 2014) Receives: Drug: Base level of remifentanil effect side concentration: 2ng/ml |
| High opioid level | Active comparator | Base level of remifentanil effect side concentration: 4ng/ml Stopped recruitment (May 2014) Receives: Drug: Base level of remifentanil effect side concentration: 4ng/ml; Other: chronic beta-blocker treatment |
| chronic beta-blocker treatment | Other | Patients with chronic beta-blocker treatment prior to surgery and study. Will all be allocated to the high opioid level arm without randomization.
Continue recruitment. Receives: Other: chronic beta-blocker treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medasense's non-invasive pain monitoring index in response to painful events
outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.
Note: during data analysis it became aparent that these definitions cannot be met. For example: the time of various clinical stimuli cannot be identified within seconds. Also, there is no meaning to a measure taken during event. Therefore, to avoid including part of the stimulus in the pre stimulus window, we restricted analysis to the first 30 seconds of the designated 1 minute before the event (-30 to -60 seconds). Similarly, the post stimulus window start was defined 10 seconds after the event annotation and the post stimulus window enlarged to 80 seconds.
Measured: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Secondary outcomes (2)
Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.
Note: same changes as in outcome 1 measure.
Measured: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs
Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken 5 minutes after.
Note: after fentanyl administration - same change as in outcome 1 measure.
Measured: at time of surgery. 1 minute before and 5 minute after analgesics administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completion25 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Edry, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762332
- Sponsor's protocol ID
- Medasense003
- Other IDs
- 0326-12-RMB
- Status last verified
- May 2015
- First submitted
- 23 Dec 2012
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
PubMed 22647429Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PubMed 23835792
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
- ClinicalTrials.gov ID
- NCT01762332
- Acronym / sponsor ID
- Medasense003
- Keywords
- nociception, analgesia, intraoperative monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- 25 May 2014 (actual)
- First posted
- 7 Jan 2013 (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.
In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been changed to NoL (Nociception Level) Index.
The PRI is based on a non-linear combination of several pain-related physiological parameters into a one unique index (0-100).
In this study we aim to validate the performance of the PRI by:
- investigating the patient's PRI response to surgical painful stimuli under different levels of analgesia:
- Investigating patient's PRI response to surgical painful stimuli under two different levels of Remifentanil Target Control Infusion (TCI) rates.
- Investigating patient's PRI response to standardized painful stimulus (Tetanic stimulus) with and without opioids.
- investigating the effect of beta-blockers on PRI performance in patients taking chronic beta-blocker treatment.
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
Detailed description
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the Numeric Pain Scale (NPS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. As a consequence, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication, leading to possible complications and adverse reactions. A validated scoring system of subject's pain level, or as in the case of an anaesthetised patient, subject's nociception level, is therefore needed.
In this study the investigators intend to test and analyze the performances of Medasense pain response index, PRI, by comparing it with other standard pain related indicators (Heart Rate (HR), Heart Rate Variability (HRV), Skin Conductance, etc) before and after painful stimuli at different levels of analgesia. In addition, in order to reduce the variability between stimuli, a standardized stimulus (Tetanic ,30 sec, 100Hz, 60mA) will be given to all patients after sleep induction and before intubation, with and without administration of Fentanyl and the values of the PRI during these stimuli will be investigated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low opioid level | Active comparator | Drug: Base level of remifentanil effect side concentration: 2ng/mlBase level of remifentanil effect side concentration: 2ng/ml Stopped recruitment (May 2014) |
| High opioid level | Active comparator | Drug: Base level of remifentanil effect side concentration: 4ng/ml, Other: chronic beta-blocker treatmentBase level of remifentanil effect side concentration: 4ng/ml Stopped recruitment (May 2014) |
| chronic beta-blocker treatment | Other | Other: chronic beta-blocker treatmentPatients with chronic beta-blocker treatment prior to surgery and study. Will all be allocated to the high opioid level arm without randomization. Continue recruitment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status 1-3
- Elective surgery
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- History of severe cardiac arrhythmias
- Abuse of alcohol or illicit drugs
- History of mental retardation, dementia, psychiatric disorders
- Allergy to any of the drugs to be used during anesthesia and recovery
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 |
|---|---|---|
| Base level of remifentanil effect side concentration: 2ng/mlAlso: Ultivaconstant remifentanil level of 2ng/ml administered using Target Control Infusion pumps. | Drug | Low opioid level |
| Base level of remifentanil effect side concentration: 4ng/mlAlso: Ultivaconstant remifentanil level of 4ng/ml administered using Target Control Infusion pumps. | Drug | High opioid level |
| chronic beta-blocker treatmentPatients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group. | Other | High opioid level, chronic beta-blocker treatment |
Primary outcome
Change in Medasense's non-invasive pain monitoring index in response to painful events
Time frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event. Note: during data analysis it became aparent that these definitions cannot be met. For example: the time of various clinical stimuli cannot be identified within seconds. Also, there is no meaning to a measure taken during event. Therefore, to avoid including part of the stimulus in the pre stimulus window, we restricted analysis to the first 30 seconds of the designated 1 minute before the event (-30 to -60 seconds). Similarly, the post stimulus window start was defined 10 seconds after the event annotation and the post stimulus window enlarged to 80 seconds.
2 secondary outcomes
Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
Time frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs
Time frame: at time of surgery. 1 minute before and 5 minute after analgesics administration
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 8 Mar 2019.
- Background: PubMed 22647429Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
- Background: PubMed 23835792Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
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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.
Ruth Edry, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base level of remifentanil effect side concentration: 2ng/ml, Base level of remifentanil effect side concentration: 4ng/ml and chronic beta-blocker treatment in people with Surgery and Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
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 8 Mar 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 Israel. 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?
Change in Medasense's non-invasive pain monitoring index in response to painful events (time frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)). 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 NCT01762332, which also lists 2 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 8 Mar 2019.