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
1 other identifier
observational
20
1 country
1
Brief Summary
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedAugust 5, 2019
June 1, 2019
4 months
October 10, 2012
December 2, 2014
June 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (9)
Mean BIS Changes After Intubation
Before vs after intubation
Mean BIS Changes 3 Min After Ketamine Bolus
Before vs 3 min after Ketamine adminstration
Mean BIS Changes After Skin Incision
Before vs after skin incision
Mean Heart Rate Change After Intubation
Before vs after intubation
Mean Heart Rate Change 3 Min After Ketamine Bolus
Before vs 3 min after Ketamine adminstration
- +4 more secondary outcomes
Other Outcomes (1)
Average Ketamine Used
Surgery
Eligibility Criteria
Women undergoing gynecological/abdominal surgery
You may qualify if:
- ASA status I, II, or III
- years or older
- Receiving GA with uncomplicated routine intubation
- Ability to provide informed consent
- English-speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Results Point of Contact
- Title
- Dr. Laurent Bollag
- Organization
- UWMC
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Bollag, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 30, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 5, 2019
Results First Posted
August 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share