Recruiting

General Anesthesia

Sponsor:

University of Washington

Code:

NCT01978379

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Pain

Study ID

NCT01978379

Start date

Oct, 2013

Status verified date

Aug, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Srdjan Jelacic, MD

206-598-3777sjelacic@uw.edu

Principal Investigator:

Srdjan Jelacic, MD

More Information

Sponsor

University of Washington

Last update posted

Aug 13, 2014

Last verified

Aug, 2014

Keywords

  • General Anesthesia
  • Nociception Level

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2014-08-13.