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

Monitoring, Intraoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717521
• Other study ID #: 42398
• Status: Completed
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monitoring, Intraoperative

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average Ketamine Used	Amount of Ketamine used during surgery	Surgery
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	Before vs after intubation
Primary	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
Primary	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
Primary	Mean ANI Changes After Skin Incision	ANI was measured pre- and post- skin incision	Before vs after skin incision
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)	Before vs after intubation
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)	Before vs 3 min after Ketamine adminstration
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)	Before vs after skin incision
Secondary	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
Secondary	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
Secondary	Mean Heart Rate Change After Skin Incision	Heart rate was measured pre- and post-skin incision.	Before vs after skin incision
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.	Before vs after intubation
Secondary	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
Secondary	Mean MAP Changes After Skin Incision	MAP was measured pre- and post- skin incision.	Before vs after skin incision