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

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ClinicalTrials.gov Identifier: NCT01717521
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Laurent Bollag, University of Washington

Tracking Information
First Submitted Date October 10, 2012
First Posted Date October 30, 2012
Results First Submitted Date December 2, 2014
Results First Posted Date August 5, 2019
Last Update Posted Date August 5, 2019
Study Start Date August 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019)
  • Mean ANI Changes After Intubation [ Time Frame: Before vs after intubation ]
    ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation
  • Mean ANI Changes 3 Min After Ketamine Bolus [ Time Frame: Before vs 3 min after Ketamine adminstration ]
    ANI was measured pre- and post- i.v. ketamine administration
  • Mean ANI Changes 5 Min After Ketamine Bolus [ Time Frame: Before vs 5 min after Ketamine adminstration ]
    ANI was measured pre- and post- i.v. ketamine administration
  • Mean ANI Changes After Skin Incision [ Time Frame: Before vs after skin incision ]
    ANI was measured pre- and post- skin incision
Original Primary Outcome Measures
 (submitted: October 25, 2012)
Analgesia Nociception Index [ Time Frame: 15-20 minutes during surgery ]
A single dimensionless number, which is a measurement for analgesia
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2019)
  • Mean BIS Changes After Intubation [ Time Frame: Before vs after intubation ]
    BIS was measured pre- and post-intubation. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
    • 100-90: awake and responding appropriately to verbal stimulation
    • 80-70: responsive to loud commands or mild shaking
    • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
    • <40: deep hypnotic state; possible protective responses still intact
    • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
    • 0: totally suppressed EEG (flat line)
  • Mean BIS Changes 3 Min After Ketamine Bolus [ Time Frame: Before vs 3 min after Ketamine adminstration ]
    BIS was measured pre- and post-Ketamine administration. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
    • 100-90: awake and responding appropriately to verbal stimulation
    • 80-70: responsive to loud commands or mild shaking
    • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
    • <40: deep hypnotic state; possible protective responses still intact
    • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
    • 0: totally suppressed EEG (flat line)
  • Mean BIS Changes After Skin Incision [ Time Frame: Before vs after skin incision ]
    BIS was measured pre- and post-skin incision. BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
    • 100-90: awake and responding appropriately to verbal stimulation
    • 80-70: responsive to loud commands or mild shaking
    • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
    • <40: deep hypnotic state; possible protective responses still intact
    • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
    • 0: totally suppressed EEG (flat line)
  • Mean Heart Rate Change After Intubation [ Time Frame: Before vs after intubation ]
    Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.
  • Mean Heart Rate Change 3 Min After Ketamine Bolus [ Time Frame: Before vs 3 min after Ketamine adminstration ]
    Heart rate was measured pre- and post- Ketamine administration
  • Mean Heart Rate Change After Skin Incision [ Time Frame: Before vs after skin incision ]
    Heart rate was measured pre- and post-skin incision.
  • Change in Mean Arterial Pressure After Intubation [ Time Frame: Before vs after intubation ]
    MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.
  • Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus [ Time Frame: Before vs 3 min after Ketamine adminstration ]
    MAP was measured pre- and post-ketamine administration
  • Mean MAP Changes After Skin Incision [ Time Frame: Before vs after skin incision ]
    MAP was measured pre- and post- skin incision.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019)
Average Ketamine Used [ Time Frame: Surgery ]
Amount of Ketamine used during surgery
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
Official Title The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
Brief Summary This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
Detailed Description

Researchers at the University of Washington 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women undergoing gynecological/abdominal surgery
Condition Monitoring, Intraoperative
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 27, 2012)
20
Original Estimated Enrollment
 (submitted: October 25, 2012)
30
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01717521
Other Study ID Numbers 42398
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Laurent Bollag, University of Washington
Study Sponsor University of Washington
Collaborators Not Provided
Investigators
Principal Investigator: Laurent Bollag, MD University of Washington
PRS Account University of Washington
Verification Date June 2019