An observational study in Monitoring, Intraoperative, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by University of Washington · Observational
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.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women undergoing gynecological/abdominal surgery
Exclusion Criteria:
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
Time frame: Before vs after intubation
Mean ANI Changes 3 Min After Ketamine Bolus
ANI was measured pre- and post- i.v. ketamine administration
Time frame: 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
Time frame: Before vs 5 min after Ketamine adminstration
Mean ANI Changes After Skin Incision
ANI was measured pre- and post- skin incision
Time frame: Before vs after skin incision
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Before vs after intubation
Mean Heart Rate Change 3 Min After Ketamine Bolus
Heart rate was measured pre- and post- Ketamine administration
Time frame: Before vs 3 min after Ketamine adminstration
Mean Heart Rate Change After Skin Incision
Heart rate was measured pre- and post-skin incision.
Time frame: 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.
Time frame: Before vs after intubation
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
MAP was measured pre- and post-ketamine administration
Time frame: Before vs 3 min after Ketamine adminstration
Mean MAP Changes After Skin Incision
MAP was measured pre- and post- skin incision.
Time frame: Before vs after skin incision
Average Ketamine Used
Amount of Ketamine used during surgery
Time frame: Surgery
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.
| Milestone | Women, Scheduled for Abdominal Hysterectomy |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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
| index | Single Group |
|---|---|
| Mean ANI Changes After Intubation | 2.11 ± 20.11 |
ANI was measured pre- and post- i.v. ketamine administration
| index | Single Group |
|---|---|
| Mean ANI Changes 3 Min After Ketamine Bolus | 1.31 ± 15.26 |
ANI was measured pre- and post- i.v. ketamine administration
| index | Single Group |
|---|---|
| Mean ANI Changes 5 Min After Ketamine Bolus | 1.95 ± 17.67 |
ANI was measured pre- and post- skin incision
| index | Single Group |
|---|---|
| Mean ANI Changes After Skin Incision | 13.65 ± 15.44 |
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)
| score on a scale | Single Group |
|---|---|
| Mean BIS Changes After Intubation | 7.25 ± 20.42 |
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)
| score on a scale | Single Group |
|---|---|
| Mean BIS Changes 3 Min After Ketamine Bolus | 3.3 ± 10.33 |
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)
| score on a scale | Single Group |
|---|---|
| Mean BIS Changes After Skin Incision | 1.9 ± 5.71 |
Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.
| bpm | Single Group |
|---|---|
| Mean Heart Rate Change After Intubation | 5 ± 9 |
Heart rate was measured pre- and post- Ketamine administration
| bpm | Single Group |
|---|---|
| Mean Heart Rate Change 3 Min After Ketamine Bolus | 2 ± 5 |
Heart rate was measured pre- and post-skin incision.
| bpm | Single Group |
|---|---|
| Mean Heart Rate Change After Skin Incision | 2 ± 6 |
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.
| mmHg | Single Group |
|---|---|
| Change in Mean Arterial Pressure After Intubation | 5.05 ± 19.99 |
MAP was measured pre- and post-ketamine administration
| mmHg | Single Group |
|---|---|
| Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus | 4.09 ± 18.52 |
MAP was measured pre- and post- skin incision.
| mmHg | Single Group |
|---|---|
| Mean MAP Changes After Skin Incision | 13.5 ± 12.6 |
Amount of Ketamine used during surgery
| mg | Single Group |
|---|---|
| Average Ketamine Used | 41.3 ± 18 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Group w Intervention | — | 0/20 (0%) | 0/20 (0%) |
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.
| Age, Continuous(years) | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Mean | 61.4 ± 11.13 |
| Sex: Female, Male(Participants) | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Female | 20 |
| Male | 0 |
| Height(cm) | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Mean | 162.3 ± 9.6 |
| Weight(kg) | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Mean | 82.3 ± 35.4 |
| BMI(kg/m^2) | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Mean | 31.3 ± 12.1 |
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