PainNCT01978379
The Nociception Level During General Anesthesia
An observational study of Pain, run by University of Washington at 1 site in United States.
Trial summary
We are conducting a study to evaluate two investigational devices that may help us better monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery. We want to collect information on how people respond to pain related to their surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center
Who may be able to join
- Patients who clinically consent to elective VATS procedure under general anesthesia,
- Ages between 18 and 80 years,
- Able to provide informed consent,
- English speaking
Who cannot join
- violation of protocol (e.g., administration of medication that does not comply with the study protocol or inability to measure NoL or ANI index)
- subject has change of mind
- surgery has to be repeated.
- Non-inclusion criteria:
- subject refusal
- non-English speaking
Show all 13Show fewer
- previous chronic or neuropathic pain
- previous chronic use of opioids
- history of psychiatric disorder
- previous ipsilateral thoracotomy or VATS
- morbidly obese with body mass index > 40
- chronically treated with beta-blockers
- unable to provide informed consent (we will not enroll subjects that require LAR consent)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Srdjan Jelacic, MD, 206-598-3777, sjelacic@uw.edu
Srdjan Jelacic, MD
About this study
Official title: The Nociception Level During Anesthesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
We are conducting a study to evaluate two investigational devices that may help us better monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery. We want to collect information on how people respond to pain related to their surgery. Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris monitors to look at measurements of pain. We will compare the measurements from the study devices to the measurements of heart rate and blood pressure. We hope to enroll about 40 subjects in this study at the University of Washington Medical Center.
Read the detailed description
The following measurements will be collected during surgery for this research study.
- Nociception Level (NoL) index The PMD-100 monitor includes a small probe similar to the pulse oximeter that will be placed on the subjects finger, which will be connected to the laptop placed next to the anesthesia machine. We will measure and record NoL index values at the following painful events: placement of breathing tube, skin incision, initial surgical instruments insertion and muscle relaxation assessment with a twitch monitor (60mA, 100Hz, 30sec). The anesthesiologist will be blinded to NoL index values that will only be collected for research purposes. We will compare the NoL index to ANI index, BP and HR. The measurements will start 5 minutes prior to the administration of general anesthesia and will continue until 5 min. after initial surgical instruments insertion.
- Analgesia Nociception Index (ANI) index The PhysioDoloris monitor attached to the IV pole will be connected with a cable to the anesthesia monitor. We will measure and record ANI index values at the following painful events: placement of breathing tube, skin incision, initial surgical instruments insertion and muscle relaxation assessment with a twitch monitor (60mA, 100Hz, 30sec). The anesthesiologist will be blinded to ANI index values that will only be collected for research purposes. The measurements will start 5 minutes prior to the administration of general anesthesia and will continue until 5 min. after initial surgical instruments insertion.
- Blood Pressure and Heart Rate We will also collect blood pressure and heart rate measurements that are generated as part of the standard anesthesia monitoring from electronic anesthesia record at 30 second intervals.
- Bispectral Index We will also collect Bispectral Index (BIS) measurements that are generated as part of the anesthesia monitoring from electronic anesthesia record at 30 second intervals. BIS is a monitor of the depth of anesthesia that uses a sensor placed on patient's forehead. BIS monitor calculates a dimensionless number estimating the patient's level of consciousness. The BIS values range from 0 (no brain activity) to 100 (fully awake) with the target range between 40 and 60 for general anesthesia.
- Pain Medication Data: We will collect the amount of pain medications used during the surgery from electronic anesthesia record.
- Conditions
- Pain
- Keywords
- General Anesthesia, Nociception Level
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Nociception Level (NoL) index
The primary objective of this study is to measure the NoL index in patients having minimally invasive lung surgery and compare it to Analgesia Nociception index (ANI), HR and BP as indicators of pain
Measured: 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia
Secondary outcomes (1)
Analgesia nociception index (ANI)
The secondary objective of this study is to measure the ANI in patients having minimally invasive lung surgery and compare it to NoL index, HR and BP as indicators of pain
Measured: 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srdjan Jelacic, University of Washington
- Investigators
- Srdjan Jelacic, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978379
- Sponsor's protocol ID
- 44750-B
- Status last verified
- Aug 2014
- First submitted
- 25 Oct 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ben-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 23835792Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.
PubMed 21095676Bollag L, Jelacic S, Delgado Upegui C, Wu C, Richebe P. The nociception level index (NOL) response to intubation and incision in patients undergoing video-assisted thoracoscopic surgery (VATS) with and without thoracic epidural analgesia. A pilot study. F1000Res. 2018 Jun 22;7:875. doi: 10.12688/f1000research.15279.1. eCollection 2018.
PubMed 30026938
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nociception Level During Anesthesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT01978379
- Acronym / sponsor ID
- 44750-B
- Conditions
- Pain
- Keywords
- General Anesthesia, Nociception Level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Nov 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.
We are conducting a study to evaluate two investigational devices that may help us better monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery. We want to collect information on how people respond to pain related to their surgery. Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris monitors to look at measurements of pain. We will compare the measurements from the study devices to the measurements of heart rate and blood pressure. We hope to enroll about 40 subjects in this study at the University of Washington Medical Center.
Detailed description
The following measurements will be collected during surgery for this research study.
- Nociception Level (NoL) index The PMD-100 monitor includes a small probe similar to the pulse oximeter that will be placed on the subjects finger, which will be connected to the laptop placed next to the anesthesia machine. We will measure and record NoL index values at the following painful events: placement of breathing tube, skin incision, initial surgical instruments insertion and muscle relaxation assessment with a twitch monitor (60mA, 100Hz, 30sec). The anesthesiologist will be blinded to NoL index values that will only be collected for research purposes. We will compare the NoL index to ANI index, BP and HR. The measurements will start 5 minutes prior to the administration of general anesthesia and will continue until 5 min. after initial surgical instruments insertion.
- Analgesia Nociception Index (ANI) index The PhysioDoloris monitor attached to the IV pole will be connected with a cable to the anesthesia monitor. We will measure and record ANI index values at the following painful events: placement of breathing tube, skin incision, initial surgical instruments insertion and muscle relaxation assessment with a twitch monitor (60mA, 100Hz, 30sec). The anesthesiologist will be blinded to ANI index values that will only be collected for research purposes. The measurements will start 5 minutes prior to the administration of general anesthesia and will continue until 5 min. after initial surgical instruments insertion.
- Blood Pressure and Heart Rate We will also collect blood pressure and heart rate measurements that are generated as part of the standard anesthesia monitoring from electronic anesthesia record at 30 second intervals.
- Bispectral Index We will also collect Bispectral Index (BIS) measurements that are generated as part of the anesthesia monitoring from electronic anesthesia record at 30 second intervals. BIS is a monitor of the depth of anesthesia that uses a sensor placed on patient's forehead. BIS monitor calculates a dimensionless number estimating the patient's level of consciousness. The BIS values range from 0 (no brain activity) to 100 (fully awake) with the target range between 40 and 60 for general anesthesia.
- Pain Medication Data: We will collect the amount of pain medications used during the surgery from electronic anesthesia record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center
Key inclusion criteria (4 listed)
- Patients who clinically consent to elective VATS procedure under general anesthesia,
- Ages between 18 and 80 years,
- Able to provide informed consent,
- English speaking
Key exclusion criteria (13 listed)
- violation of protocol (e.g., administration of medication that does not comply with the study protocol or inability to measure NoL or ANI index)
- subject has change of mind
- surgery has to be repeated.
- subject refusal
- non-English speaking
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
Nociception Level (NoL) index
Time frame: 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia
The primary objective of this study is to measure the NoL index in patients having minimally invasive lung surgery and compare it to Analgesia Nociception index (ANI), HR and BP as indicators of pain
1 secondary outcome
Analgesia nociception index (ANI)
Time frame: 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- 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.
- Background: PubMed 21095676Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.
- Derived from this study: PubMed 30026938Bollag L, Jelacic S, Delgado Upegui C, Wu C, Richebe P. The nociception level index (NOL) response to intubation and incision in patients undergoing video-assisted thoracoscopic surgery (VATS) with and without thoracic epidural analgesia. A pilot study. F1000Res. 2018 Jun 22;7:875. doi: 10.12688/f1000research.15279.1. eCollection 2018.
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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.
Srdjan Jelacic, MD principal investigator
University of Washington
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 Pain, run by University of Washington at 1 site in United States.
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 13 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 13 Aug 2014. 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 United States. 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?
Nociception Level (NoL) index (time frame: 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia). 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 NCT01978379, which also lists 3 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 13 Aug 2014.