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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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- University of Washington
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Mean ANI Changes After Intubation
Tijdsspanne: Before vs after intubation
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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
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Before vs after intubation
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Mean ANI Changes 3 Min After Ketamine Bolus
Tijdsspanne: Before vs 3 min after Ketamine adminstration
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ANI was measured pre- and post- i.v.
ketamine administration
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Before vs 3 min after Ketamine adminstration
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Mean ANI Changes 5 Min After Ketamine Bolus
Tijdsspanne: Before vs 5 min after Ketamine adminstration
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ANI was measured pre- and post- i.v.
ketamine administration
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Before vs 5 min after Ketamine adminstration
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Mean ANI Changes After Skin Incision
Tijdsspanne: Before vs after skin incision
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ANI was measured pre- and post- skin incision
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Before vs after skin incision
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Mean BIS Changes After Intubation
Tijdsspanne: Before vs after intubation
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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).
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Before vs after intubation
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Mean BIS Changes 3 Min After Ketamine Bolus
Tijdsspanne: 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).
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Before vs 3 min after Ketamine adminstration
|
Mean BIS Changes After Skin Incision
Tijdsspanne: 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).
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Before vs after skin incision
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Mean Heart Rate Change After Intubation
Tijdsspanne: Before vs after intubation
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Heart rate assessed by continuous pulse oximetry.
Heart rate was measured pre- and post-intubation.
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Before vs after intubation
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Mean Heart Rate Change 3 Min After Ketamine Bolus
Tijdsspanne: Before vs 3 min after Ketamine adminstration
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Heart rate was measured pre- and post- Ketamine administration
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Before vs 3 min after Ketamine adminstration
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Mean Heart Rate Change After Skin Incision
Tijdsspanne: Before vs after skin incision
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Heart rate was measured pre- and post-skin incision.
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Before vs after skin incision
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Change in Mean Arterial Pressure After Intubation
Tijdsspanne: Before vs after intubation
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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.
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Before vs after intubation
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Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
Tijdsspanne: Before vs 3 min after Ketamine adminstration
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MAP was measured pre- and post-ketamine administration
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Before vs 3 min after Ketamine adminstration
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Mean MAP Changes After Skin Incision
Tijdsspanne: Before vs after skin incision
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MAP was measured pre- and post- skin incision.
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Before vs after skin incision
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Average Ketamine Used
Tijdsspanne: Surgery
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Amount of Ketamine used during surgery
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Surgery
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Laurent Bollag, MD, University of Washington
Studie record data
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Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 42398
Plan Individuele Deelnemersgegevens (IPD)
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