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

The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device

This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)

Study Overview

• Status: Completed
• Conditions: Monitoring, Intraoperative

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing gynecological/abdominal surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).; 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)	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)	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Ketamine Used	Amount of Ketamine used during surgery	Surgery

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Laurent Bollag, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: hysterectomy; intraoperative monitoring; robotic-assisted; abdominal gynecological surgery
• Other Study ID Numbers: 42398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO