Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01978379
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2013-10-25
Brief Title:
The Nociception Level During General Anesthesia
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The Nociception Level During Anesthesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
1 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
2 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
3 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
4 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 patients forehead BIS monitor calculates a dimensionless number estimating the patients 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
5 Pain Medication Data We will collect the amount of pain medications used during the surgery from electronic anesthesia record
1 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
2 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
3 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
4 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 patients forehead BIS monitor calculates a dimensionless number estimating the patients 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
5 Pain Medication Data We will collect the amount of pain medications used during the surgery from electronic anesthesia record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None