Trial record 14 of 33 for:    Open Studies | "Pain Perception"

The Nociception Level During General Anesthesia

This study is currently recruiting participants.
Verified October 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Srdjan Jelacic, University of Washington
ClinicalTrials.gov Identifier:
NCT01978379
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nociception Level During Anesthesia in Patients Undergoing Video-assisted Thoracoscopic Surgery

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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 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.
  5. Pain Medication Data: We will collect the amount of pain medications used during the surgery from electronic anesthesia record.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center

Criteria

Inclusion Criteria:

  1. Patients who clinically consent to elective VATS procedure under general anesthesia,
  2. Ages between 18 and 80 years,
  3. Able to provide informed consent,
  4. English speaking

Exclusion criteria:

  1. violation of protocol (e.g., administration of medication that does not comply with the study protocol or inability to measure NoL or ANI index)
  2. subject has change of mind
  3. surgery has to be repeated.

Non-inclusion criteria:

  1. subject refusal
  2. non-English speaking
  3. previous chronic or neuropathic pain
  4. previous chronic use of opioids
  5. history of psychiatric disorder
  6. previous ipsilateral thoracotomy or VATS
  7. morbidly obese with body mass index > 40
  8. chronically treated with beta-blockers
  9. unable to provide informed consent (we will not enroll subjects that require LAR consent)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978379

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Srdjan Jelacic, MD    206-598-3777    sjelacic@uw.edu   
Principal Investigator: Srdjan Jelacic, MD         
Sub-Investigator: Laurent Bollag, MD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Srdjan Jelacic, MD University of Washington
  More Information

Publications:
Responsible Party: Srdjan Jelacic, Acting Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01978379     History of Changes
Other Study ID Numbers: 44750-B
Study First Received: October 25, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
General Anesthesia
Nociception Level

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014