Trial record 14 of 32 for:
Open Studies | "Pain Perception"
The Nociception Level During General Anesthesia
Verified October 2013 by University of Washington
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Nociception Level During Anesthesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center
- Patients who clinically consent to elective VATS procedure under general anesthesia,
- Ages between 18 and 80 years,
- Able to provide informed consent,
- English speaking
- 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978379
|University of Washington Medical Center
|Seattle, Washington, United States, 98195 |
|Contact: Srdjan Jelacic, MD 206-598-3777 firstname.lastname@example.org |
|Principal Investigator: Srdjan Jelacic, MD |
|Sub-Investigator: Laurent Bollag, MD |
University of Washington
||Srdjan Jelacic, MD
||University of Washington
||Srdjan Jelacic, Acting Assistant Professor, University of Washington
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2013
||October 31, 2013
||United States: Institutional Review Board
Keywords provided by University of Washington:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents