NCT01631695

Brief Summary

In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU). The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

2.5 years

First QC Date

October 24, 2011

Last Update Submit

October 27, 2013

Conditions

SurgeryPainPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Changes in Medasense's non-invasive pain monitoring index in response to painful events.

    outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.

    before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)

Secondary Outcomes (3)

  • Changes in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli

    before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)

  • Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli

    before versus after painful stimuli (for instance: intubation, skin incision, trocar insertion)

  • Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs

    before versus after analgesic drug administration

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective surgeries under general anesthesia, healthy or suffering from minor chronic diseases (ASA I-II)

You may qualify if:

  • ASA physical status 1-2
  • Elective surgery under general anesthesia
  • Baseline blood pressure \< (170\\100 mmHg), heart rate \< 100 bpm

You may not qualify if:

  • Pregnancy or lactation
  • History of severe cardiac arrhythmias
  • Presence of any neuromuscular or neurological disease
  • Use of central nervous system (CNS) -active medications
  • Abuse of alcohol or illicit drugs
  • History of mental retardation or any mental disease
  • Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
  • Use of a α or β-adrenergic antagonist or anticholinergics
  • Allergy to any of the drugs to be used during surgery
  • Use of regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (2)

  • Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.

    PMID: 22647429BACKGROUND

  • 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.

    PMID: 23835792RESULT

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ruth Edry, MD

    Department of Anesthesiology, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

June 29, 2012

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

IL(1)