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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laurent Bollag, University of Washington
ClinicalTrials.gov Identifier:
NCT01717521
First received: October 10, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Abdominal Gynecological Surgeries

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Analgesia Nociception Index [ Time Frame: 15-20 minutes during surgery ] [ Designated as safety issue: Yes ]
    A single dimensionless number, which is a measurement for analgesia


Enrollment: 20
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing gynecological/abdominal surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717521

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
  More Information

No publications provided

Responsible Party: Laurent Bollag, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01717521     History of Changes
Other Study ID Numbers: 42398
Study First Received: October 10, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
hysterectomy
gynecological abdominal surgery

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

ClinicalTrials.gov processed this record on May 19, 2013