N/A
N=20
Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
Monitoring, Intraoperative
Bottom Line
View on ClinicalTrials.gov: NCT01717521 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Mean ANI Changes After Intubation — 2.11 index
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean ANI Changes After Intubation |
2.11 | — |
| PRIMARY Mean ANI Changes 3 Min After Ketamine Bolus |
1.31 | — |
| PRIMARY Mean ANI Changes 5 Min After Ketamine Bolus |
1.95 | — |
| PRIMARY Mean ANI Changes After Skin Incision |
13.65 | — |
| SECONDARY Mean BIS Changes After Intubation |
7.25 | — |
| SECONDARY Mean BIS Changes 3 Min After Ketamine Bolus |
3.3 | — |
| SECONDARY Mean BIS Changes After Skin Incision |
1.9 | — |
| SECONDARY Mean Heart Rate Change After Intubation |
5 | — |
| SECONDARY Mean Heart Rate Change 3 Min After Ketamine Bolus |
2 | — |
| SECONDARY Mean Heart Rate Change After Skin Incision |
2 | — |
| SECONDARY Change in Mean Arterial Pressure After Intubation |
5.05 | — |
| SECONDARY Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus |
4.09 | — |
| SECONDARY Mean MAP Changes After Skin Incision |
13.5 | — |
Summary
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
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
Data sourced from ClinicalTrials.gov (NCT01717521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.