Clinical trial NCT01717521: Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
Official title: The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring, Intraoperative
Keywords: intraoperative monitoring
hysterectomy
robotic-assisted
abdominal gynecological surgery
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing gynecological/abdominal surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean ANI Changes After Intubation
timeFrame: Before vs after intubation
measure: Mean ANI Changes 3 Min After Ketamine Bolus
timeFrame: Before vs 3 min after Ketamine adminstration
measure: Mean ANI Changes 5 Min After Ketamine Bolus
timeFrame: Before vs 5 min after Ketamine adminstration
measure: Mean ANI Changes After Skin Incision
timeFrame: Before vs after skin incision
Secondary outcomes:
measure: Mean BIS Changes After Intubation
timeFrame: Before vs after intubation
measure: Mean BIS Changes 3 Min After Ketamine Bolus
timeFrame: Before vs 3 min after Ketamine adminstration
measure: Mean BIS Changes After Skin Incision
timeFrame: Before vs after skin incision
measure: Mean Heart Rate Change After Intubation
timeFrame: Before vs after intubation
measure: Mean Heart Rate Change 3 Min After Ketamine Bolus
timeFrame: Before vs 3 min after Ketamine adminstration
measure: Mean Heart Rate Change After Skin Incision
timeFrame: Before vs after skin incision
measure: Change in Mean Arterial Pressure After Intubation
timeFrame: Before vs after intubation
measure: Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
timeFrame: Before vs 3 min after Ketamine adminstration
measure: Mean MAP Changes After Skin Incision
timeFrame: Before vs after skin incision
Other outcomes:
measure: Average Ketamine Used
timeFrame: Surgery
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Laurent Bollag, MD
role: PRINCIPAL_INVESTIGATOR
References: