Monitoring, Intraoperative
Conditions
Keywords
intraoperative monitoring, hysterectomy, robotic-assisted, abdominal gynecological surgery
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.
Interventions
None listed
Sponsors
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean ANI Changes After Skin Incision | Before vs after skin incision | ANI was measured pre- and post- skin incision |
| Mean ANI Changes After Intubation | 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 | 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 | Before vs 5 min after Ketamine adminstration | ANI was measured pre- and post- i.v. ketamine administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heart Rate Change After Intubation | 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 | Before vs 3 min after Ketamine adminstration | Heart rate was measured pre- and post- Ketamine administration |
| Mean Heart Rate Change After Skin Incision | Before vs after skin incision | Heart rate was measured pre- and post-skin incision. |
| Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus | Before vs 3 min after Ketamine adminstration | MAP was measured pre- and post-ketamine administration |
| Mean MAP Changes After Skin Incision | Before vs after skin incision | MAP was measured pre- and post- skin incision. |
| Change in Mean Arterial Pressure After Intubation | 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. |
| Mean BIS Changes After Intubation | 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 | 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 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Ketamine Used | Surgery | Amount of Ketamine used during surgery |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Women Scheduled for Abdominal Hysterectomies. Inclusion criteria : \>18yrs, ASA 1-3, Scheduled for abdominal hysterectomies under general anesthesia | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Women Scheduled for Abdominal Hysterectomies. |
|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 11.13 |
| BMI | 31.3 kg/m^2 STANDARD_DEVIATION 12.1 |
| Height | 162.3 cm STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 82.3 kg STANDARD_DEVIATION 35.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean ANI Changes 3 Min After Ketamine Bolus | 1.31 index | Standard Deviation 15.26 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean ANI Changes 5 Min After Ketamine Bolus | 1.95 index | Standard Deviation 17.67 |
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
Time frame: Before vs after intubation
Population: This pilot study included 20 women undergoing abdominal hysterectomies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean ANI Changes After Intubation | 2.11 index | Standard Deviation 20.11 |
Primary
Mean ANI Changes After Skin Incision
ANI was measured pre- and post- skin incision
Time frame: Before vs after skin incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean ANI Changes After Skin Incision | 13.65 index | Standard Deviation 15.44 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus | 4.09 mmHg | Standard Deviation 18.52 |
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.
Time frame: Before vs after intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Change in Mean Arterial Pressure After Intubation | 5.05 mmHg | Standard Deviation 19.99 |
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). * 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean BIS Changes 3 Min After Ketamine Bolus | 3.3 score on a scale | Standard Deviation 10.33 |
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). * 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean BIS Changes After Intubation | 7.25 score on a scale | Standard Deviation 20.42 |
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). * 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean BIS Changes After Skin Incision | 1.9 score on a scale | Standard Deviation 5.71 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean Heart Rate Change 3 Min After Ketamine Bolus | 2 bpm | Standard Deviation 5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean Heart Rate Change After Intubation | 5 bpm | Standard Deviation 9 |
Secondary
Mean Heart Rate Change After Skin Incision
Heart rate was measured pre- and post-skin incision.
Time frame: Before vs after skin incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean Heart Rate Change After Skin Incision | 2 bpm | Standard Deviation 6 |
Secondary
Mean MAP Changes After Skin Incision
MAP was measured pre- and post- skin incision.
Time frame: Before vs after skin incision
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Mean MAP Changes After Skin Incision | 13.5 mmHg | Standard Deviation 12.6 |
Other Pre-specified
Average Ketamine Used
Amount of Ketamine used during surgery
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Average Ketamine Used | 41.3 mg | Standard Deviation 18 |