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

University of Washington20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Monitoring, Intraoperative

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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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