Trial Outcomes & Findings for Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris (NCT NCT01717521)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

Before vs after intubation

Results posted on

2019-08-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Scheduled for Abdominal Hysterectomies. n=20 Participants Inclusion criteria : \>18yrs, ASA 1-3, Scheduled for abdominal hysterectomies under general anesthesia
Age, Continuous	61.4 years STANDARD_DEVIATION 11.13 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Height	162.3 cm STANDARD_DEVIATION 9.6 • n=5 Participants
Weight	82.3 kg STANDARD_DEVIATION 35.4 • n=5 Participants
BMI	31.3 kg/m^2 STANDARD_DEVIATION 12.1 • n=5 Participants

PRIMARY outcome

Timeframe: Before vs after intubation

Population: This pilot study included 20 women undergoing abdominal hysterectomies

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

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean ANI Changes After Intubation	2.11 index Standard Deviation 20.11

PRIMARY outcome

Timeframe: Before vs 3 min after Ketamine adminstration

ANI was measured pre- and post- i.v. ketamine administration

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean ANI Changes 3 Min After Ketamine Bolus	1.31 index Standard Deviation 15.26

PRIMARY outcome

Timeframe: Before vs 5 min after Ketamine adminstration

ANI was measured pre- and post- i.v. ketamine administration

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean ANI Changes 5 Min After Ketamine Bolus	1.95 index Standard Deviation 17.67

PRIMARY outcome

Timeframe: Before vs after skin incision

ANI was measured pre- and post- skin incision

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean ANI Changes After Skin Incision	13.65 index Standard Deviation 15.44

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean BIS Changes After Intubation	7.25 score on a scale Standard Deviation 20.42

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean BIS Changes 3 Min After Ketamine Bolus	3.3 score on a scale Standard Deviation 10.33

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean BIS Changes After Skin Incision	1.9 score on a scale Standard Deviation 5.71

SECONDARY outcome

Timeframe: Before vs after intubation

Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean Heart Rate Change After Intubation	5 bpm Standard Deviation 9

SECONDARY outcome

Timeframe: Before vs 3 min after Ketamine adminstration

Heart rate was measured pre- and post- Ketamine administration

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean Heart Rate Change 3 Min After Ketamine Bolus	2 bpm Standard Deviation 5

SECONDARY outcome

Timeframe: Before vs after skin incision

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

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean Heart Rate Change After Skin Incision	2 bpm Standard Deviation 6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Change in Mean Arterial Pressure After Intubation	5.05 mmHg Standard Deviation 19.99

SECONDARY outcome

Timeframe: Before vs 3 min after Ketamine adminstration

MAP was measured pre- and post-ketamine administration

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus	4.09 mmHg Standard Deviation 18.52

SECONDARY outcome

Timeframe: Before vs after skin incision

MAP was measured pre- and post- skin incision.

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Mean MAP Changes After Skin Incision	13.5 mmHg Standard Deviation 12.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Surgery

Amount of Ketamine used during surgery

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants Participants undergoing abdominal hysterectomy under sevoflurane anesthesia
Average Ketamine Used	41.3 mg Standard Deviation 18

Adverse Events

Single Group w Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laurent Bollag

UWMC

Phone: 2063277328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place