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

24 de junho de 2019 atualizado por: 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)

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

20

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

Women undergoing gynecological/abdominal surgery

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean ANI Changes After Intubation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Before vs after skin incision
ANI was measured pre- and post- skin incision
Before vs after skin incision

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean BIS Changes After Intubation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Before vs after skin incision
MAP was measured pre- and post- skin incision.
Before vs after skin incision

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Average Ketamine Used
Prazo: Surgery
Amount of Ketamine used during surgery
Surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Washington

Investigadores

  • Investigador principal: Laurent Bollag, MD, University of Washington

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2012

Conclusão Primária (Real)

1 de dezembro de 2012

Conclusão do estudo (Real)

1 de dezembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

10 de outubro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de outubro de 2012

Primeira postagem (Estimativa)

30 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de junho de 2019

Última verificação

1 de junho de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 42398

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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