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NCT Number: NCT01717521

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

This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)

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Key information

Conditions

Monitoring, Intraoperative

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Mean ANI Changes After Skin Incision

    Time frame: Before vs after skin incision

    ANI was measured pre- and post- skin incision

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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

  6. Mean Heart Rate Change After Skin Incision

    Time frame: Before vs after skin incision

    Heart rate was measured pre- and post-skin incision.

  7. 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.

  8. 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

  9. Mean MAP Changes After Skin Incision

    Time frame: Before vs after skin incision

    MAP was measured pre- and post- skin incision.

Other outcomes

  1. Average Ketamine Used

    Time frame: Surgery

    Amount of Ketamine used during surgery

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2012
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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