Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717521
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
Laurent Bollag, University of Washington

Brief Summary:

Researchers at the UW are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.

The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.

Condition or disease
Abdominal Gynecological Surgeries

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources


Primary Outcome Measures :
  1. Analgesia Nociception Index [ Time Frame: 15-20 minutes during surgery ]
    A single dimensionless number, which is a measurement for analgesia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing gynecological/abdominal surgery

Inclusion Criteria:

  • ASA status I, II, or III
  • 18 years or older
  • Receiving GA with uncomplicated routine intubation
  • Ability to provide informed consent
  • English-speaking

Exclusion Criteria:

  • Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
  • Patient refusal
  • History of substance abuse
  • Patients taking psychotropic and/or opiate drugs
  • Having a history of psychiatric diseases or psychological problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717521

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington

Responsible Party: Laurent Bollag, Assistant Professor, University of Washington Identifier: NCT01717521     History of Changes
Other Study ID Numbers: 42398
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Laurent Bollag, University of Washington:
gynecological abdominal surgery

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action