- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01717521
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98195
- University of Washington
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean ANI Changes After Intubation
Tidsramme: Before vs 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
Tidsramme: Before vs 3 min after Ketamine adminstration
|
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
Tidsramme: Before vs 5 min after Ketamine adminstration
|
ANI was measured pre- and post- i.v.
ketamine administration
|
Before vs 5 min after Ketamine adminstration
|
Mean ANI Changes After Skin Incision
Tidsramme: Before vs after skin incision
|
ANI was measured pre- and post- skin incision
|
Before vs after skin incision
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean BIS Changes After Intubation
Tidsramme: Before vs 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).
|
Before vs after intubation
|
Mean BIS Changes 3 Min After Ketamine Bolus
Tidsramme: 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).
|
Before vs 3 min after Ketamine adminstration
|
Mean BIS Changes After Skin Incision
Tidsramme: 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).
|
Before vs after skin incision
|
Mean Heart Rate Change After Intubation
Tidsramme: Before vs after intubation
|
Heart rate assessed by continuous pulse oximetry.
Heart rate was measured pre- and post-intubation.
|
Before vs after intubation
|
Mean Heart Rate Change 3 Min After Ketamine Bolus
Tidsramme: Before vs 3 min after Ketamine adminstration
|
Heart rate was measured pre- and post- Ketamine administration
|
Before vs 3 min after Ketamine adminstration
|
Mean Heart Rate Change After Skin Incision
Tidsramme: Before vs after skin incision
|
Heart rate was measured pre- and post-skin incision.
|
Before vs after skin incision
|
Change in Mean Arterial Pressure After Intubation
Tidsramme: Before vs 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
|
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
Tidsramme: Before vs 3 min after Ketamine adminstration
|
MAP was measured pre- and post-ketamine administration
|
Before vs 3 min after Ketamine adminstration
|
Mean MAP Changes After Skin Incision
Tidsramme: Before vs after skin incision
|
MAP was measured pre- and post- skin incision.
|
Before vs after skin incision
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Average Ketamine Used
Tidsramme: Surgery
|
Amount of Ketamine used during surgery
|
Surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Laurent Bollag, MD, University of Washington
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 42398
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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