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This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
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.
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| 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 |
| 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).
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| Measure | Description | Time Frame |
|---|---|---|
| Average Ketamine Used | Amount of Ketamine used during surgery | Surgery |
Inclusion Criteria:
Exclusion Criteria:
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Women undergoing gynecological/abdominal surgery
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Bollag, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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After institutional review board approval, this observational pilot study was conducted at the University of Washington Medical Center (UWMC). Twenty women, 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under sevoflurane anesthesia were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Women, Scheduled for Abdominal Hysterectomy | Women 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under general anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty women, 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under sevoflurane anesthesia were recruited.
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| ID | Title | Description |
|---|---|---|
| BG000 | Women Scheduled for Abdominal Hysterectomies. | Inclusion criteria : >18yrs, ASA 1-3, Scheduled for abdominal hysterectomies under general anesthesia |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This pilot study included 20 women undergoing abdominal hysterectomies | Posted | Mean | Standard Deviation | index | Before vs after intubation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Group w Intervention | no adverse events were observed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurent Bollag | UWMC | 2063277328 | bollag@uw.edu |
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| 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).
| 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).
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Primary | Mean ANI Changes 3 Min After Ketamine Bolus | ANI was measured pre- and post- i.v. ketamine administration | Posted | Mean | Standard Deviation | index | Before vs 3 min after Ketamine adminstration |
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| Primary | Mean ANI Changes 5 Min After Ketamine Bolus | ANI was measured pre- and post- i.v. ketamine administration | Posted | Mean | Standard Deviation | index | Before vs 5 min after Ketamine adminstration |
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| Primary | Mean ANI Changes After Skin Incision | ANI was measured pre- and post- skin incision | Posted | Mean | Standard Deviation | index | Before vs after skin incision |
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| Secondary | 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).
| Posted | Mean | Standard Deviation | score on a scale | Before vs after intubation |
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| Secondary | 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).
| Posted | Mean | Standard Deviation | score on a scale | Before vs 3 min after Ketamine adminstration |
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| Secondary | 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).
| Posted | Mean | Standard Deviation | score on a scale | Before vs after skin incision |
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| Secondary | Mean Heart Rate Change After Intubation | Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation. | Posted | Mean | Standard Deviation | bpm | Before vs after intubation |
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| Secondary | Mean Heart Rate Change 3 Min After Ketamine Bolus | Heart rate was measured pre- and post- Ketamine administration | Posted | Mean | Standard Deviation | bpm | Before vs 3 min after Ketamine adminstration |
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| Secondary | Mean Heart Rate Change After Skin Incision | Heart rate was measured pre- and post-skin incision. | Posted | Mean | Standard Deviation | bpm | Before vs after skin incision |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Before vs after intubation |
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| Secondary | Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus | MAP was measured pre- and post-ketamine administration | Posted | Mean | Standard Deviation | mmHg | Before vs 3 min after Ketamine adminstration |
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| Secondary | Mean MAP Changes After Skin Incision | MAP was measured pre- and post- skin incision. | Posted | Mean | Standard Deviation | mmHg | Before vs after skin incision |
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| Other Pre-specified | Average Ketamine Used | Amount of Ketamine used during surgery | Posted | Mean | Standard Deviation | mg | Surgery |
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| 0 |
| 20 |
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| 20 |
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