SurgeryNCT01631695
Clinical Evaluation of Medasense Pain Monitor Performances
An observational study of Surgery and Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery, Pain, Postoperative Pain
- How many people
- 96 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to May 2012
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgeries under general anesthesia, healthy or suffering from minor chronic diseases (ASA I-II)
Who may be able to join
- ASA physical status 1-2
- Elective surgery under general anesthesia
- Baseline blood pressure < (170\100 mmHg), heart rate < 100 bpm
Who cannot join
- Pregnancy or lactation
- History of severe cardiac arrhythmias
- Presence of any neuromuscular or neurological disease
- Use of central nervous system (CNS) -active medications
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
Show all 10Show fewer
- Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
- Use of a α or β-adrenergic antagonist or anticholinergics
- Allergy to any of the drugs to be used during surgery
- Use of regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist
In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).
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 visual analog scale (VAS), 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. Therefore, 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. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
- Conditions
- Surgery, Pain, Postoperative Pain
- Medical subject headings
- Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes 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.
Measured: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Secondary outcomes (3)
Changes 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.
Measured: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli
Outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.
Measured: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Changes in Medasense index/pain related 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 one minute after.
Participants will be followed for the duration of surgery and Postoperative Recovery.
Measured: before versus after analgesic drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 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, Department of Anesthesiology, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631695
- Sponsor's protocol ID
- Medasense002
- Other IDs
- 0281-09-RMB
- Status last verified
- Oct 2013
- First submitted
- 24 Oct 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist
- ClinicalTrials.gov ID
- NCT01631695
- Acronym / sponsor ID
- Medasense002
- Conditions
- Surgery, Pain, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 2012 (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 this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).
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 visual analog scale (VAS), 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. Therefore, 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. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgeries under general anesthesia, healthy or suffering from minor chronic diseases (ASA I-II)
Key inclusion criteria (3 listed)
- ASA physical status 1-2
- Elective surgery under general anesthesia
- Baseline blood pressure < (170\100 mmHg), heart rate < 100 bpm
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- History of severe cardiac arrhythmias
- Presence of any neuromuscular or neurological disease
- Use of central nervous system (CNS) -active medications
- Abuse of alcohol or illicit drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Medasense's non-invasive pain monitoring index in response to painful events.
Time frame: before versus 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.
3 secondary outcomes
Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli
Time frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli
Time frame: before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)
Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs
Time frame: before versus after analgesic drug 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 29 Oct 2013.
- 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.
- Results publication: 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
Department of Anesthesiology, 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?
An observational study of 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 3 inclusion and 10 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 29 Oct 2013. 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?
Changes in Medasense's non-invasive pain monitoring index in response to painful events. (time frame: before versus 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 NCT01631695, 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 29 Oct 2013.