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

Completed

• Conditions: Monitoring, Intraoperative

• Registration Number: NCT01717521
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-12-02
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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 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)
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.
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 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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States