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

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

Detailed Description
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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.

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

Conditions
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Monitoring, Intraoperative

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ANI Changes 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 | Before vs after intubation | 
| Mean ANI Changes 3 Min After Ketamine Bolus | ANI was measured pre- and post- i.v. ketamine administration | Before vs 3 min after Ketamine adminstration | 
| Mean ANI Changes 5 Min After Ketamine Bolus | ANI was measured pre- and post- i.v. ketamine administration | Before vs 5 min after Ketamine adminstration | 
| Mean ANI Changes After Skin Incision | ANI was measured pre- and post- skin incision | Before vs after skin incision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean BIS Changes 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) | Before vs after intubation | 
| Mean BIS Changes 3 Min After Ketamine Bolus | 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) | Before vs 3 min after Ketamine adminstration | 
| Mean BIS Changes 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) | Before vs after skin incision | 
| Mean Heart Rate Change After Intubation | Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation. | Before vs after intubation | 
| Mean Heart Rate Change 3 Min After Ketamine Bolus | Heart rate was measured pre- and post- Ketamine administration | Before vs 3 min after Ketamine adminstration | 
| Mean Heart Rate Change After Skin Incision | Heart rate was measured pre- and post-skin incision. | Before vs after skin incision | 
| Change in Mean Arterial Pressure 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. | Before vs after intubation | 
| Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus | MAP was measured pre- and post-ketamine administration | Before vs 3 min after Ketamine adminstration | 
| Mean MAP Changes After Skin Incision | MAP was measured pre- and post- skin incision. | Before vs after skin incision | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative monitoring, hysterectomy, robotic-assisted, abdominal gynecological surgery