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Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris

24. juni 2019 opdateret af: Laurent Bollag, University of Washington

The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device

This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women undergoing gynecological/abdominal surgery

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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).

  • 100-90: awake and responding appropriately to verbal stimulation
  • 80-70: responsive to loud commands or mild shaking
  • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
  • <40: deep hypnotic state; possible protective responses still intact
  • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
  • 0: totally suppressed EEG (flat line)
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).

  • 100-90: awake and responding appropriately to verbal stimulation
  • 80-70: responsive to loud commands or mild shaking
  • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
  • <40: deep hypnotic state; possible protective responses still intact
  • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
  • 0: totally suppressed EEG (flat line)
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).

  • 100-90: awake and responding appropriately to verbal stimulation
  • 80-70: responsive to loud commands or mild shaking
  • 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
  • <40: deep hypnotic state; possible protective responses still intact
  • <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
  • 0: totally suppressed EEG (flat line)
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
Foranstaltningsbeskrivelse
Tidsramme
Average Ketamine Used
Tidsramme: Surgery
Amount of Ketamine used during surgery
Surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Efterforskere

  • Ledende efterforsker: Laurent Bollag, MD, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

10. oktober 2012

Først indsendt, der opfyldte QC-kriterier

25. oktober 2012

Først opslået (Skøn)

30. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 42398

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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