Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy

2 de marzo de 2020 actualizado por: NYU Langone Health

Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries

This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery.

Descripción general del estudio

Estado

Terminado

Descripción detallada

This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery. Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ketamine (0.4mg/kg) or matching placebo. Both men and women will be recruited, and there is no limitation as to racial and ethnic origin. In the PACU, patients will receive either 0.4mg/kg IV ketamine or placebo. All patients will also receive standard post-anesthetic monitoring and care, as well as routine care after transfer out of the PACU. Patients are followed until the date of discharge, and endpoints (see below) are collected from patient reports as well as from medical charts. During their hospital stay (and once after their discharge from the hospital), patients will fill out five questionnaires which provide estimates of their postoperative pain control, mood and function, and quality of postsurgical recovery. An additional component of the study, which is entirely optional, is to obtain patient serum samples (about two teaspoons) in the operating room and 15 minutes and 4 hours after ketamine infusion. The investigators will use these samples to assess levels of IL-1, IL-6, TNF-α, and BDNF, which are markers for pain. In addition, with patient consent, the investigators will also store serum samples for future research use to measure other cytokines and neurotrophic factors and molecular markers associated with pain and depression.

Tipo de estudio

Intervencionista

Inscripción (Actual)

90

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10016
        • NYU Langone Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Adults, >18 years, <65 years, who will undergo gastric bypass or sleeve gastrectomy.
  2. Subject is non-lactating and is either:

    • Not of childbearing potential; or
    • Of childbearing potential but is not pregnant at time of baseline as determined by pre-operative pregnancy testing.
  3. Subject is ASA physical status 1, 2, or 3.
  4. Subject who is deemed medically stable

Exclusion Criteria:

  1. <18 years of age; >65 years of age
  2. Pregnant or breastfeeding
  3. Does not speak or understand English (the study forms used are copy-righted in English)
  4. Cognitively impairment (by history) or clinical signs of altered mental status
  5. History of misuse or abuse of ketamine
  6. History of chest pain or chest pain in the PACU
  7. Use of a medication that interferes with metabolism of ketamine within the last 24 hours
  8. A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use
  9. History of head trauma
  10. History of intracranial mass or hemorrhage
  11. History of stroke
  12. History of cardiac arrhythmia
  13. Subject for whom ketamine is contraindicated
  14. Unwillingness to give informed consent according to HIC guidelines

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: treatment/placebo
saline infusion
0.4mg/kg infusion
Otros nombres:
  • Infusión Salina
Experimental: treatment
ketamine (0.4mg/kg)
0.4mg/kg infusion
Otros nombres:
  • Ketalar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Pain Scores
Periodo de tiempo: Baseline (DOS) to 7 days (Post Op)
VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.
Baseline (DOS) to 7 days (Post Op)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Length of Stay During Hospitalization
Periodo de tiempo: 8 days
LOS will be recorded from medical record.
8 days

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion
Periodo de tiempo: 8 Days
Length of stay and opioid usage will be recorded from electronic medical chart
8 Days
Opioid Usage Per Day Throughout the Hospital Stay
Periodo de tiempo: 8 days
recorded from medical chart
8 days
Time to Out of Bed to Chair (OOB)
Periodo de tiempo: 7 Days
Patient will be asked to record and report the time to OOB
7 Days
Spirometry Use 4 Hours After the Termination of Ketamine Infusion
Periodo de tiempo: 1 day
Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.
1 day
Change in Serum Level of IL-1 After Ketamine Infusion
Periodo de tiempo: 1 day
changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
1 day
Survey Scores - McGill's Short Form
Periodo de tiempo: Pre-op,Day of Surgery through Post-op Day 8
Change in survey scores -- McGill's short form
Pre-op,Day of Surgery through Post-op Day 8
Survey Scores - Becks Depression Index (BDI)
Periodo de tiempo: Pre-op,Day of Surgery through Post-op Day 8
Change in survey scores for Becks Depression Index (BDI)
Pre-op,Day of Surgery through Post-op Day 8
Survey Scores - QoR15
Periodo de tiempo: Pre-op,Day of Surgery through Post-op Day 8
Change in scores for Quality of Recovery 15 - QoR15
Pre-op,Day of Surgery through Post-op Day 8
Survey Scores - MADRS
Periodo de tiempo: Pre-op,Day of Surgery through Post-op Day 8
Change in scores for MADRS
Pre-op,Day of Surgery through Post-op Day 8
Change in Serum Level of IL-6 After Ketamine Infusion
Periodo de tiempo: 1 day
changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
1 day
Change in Serum Level of TNF-α After Ketamine Infusion
Periodo de tiempo: 1 day
changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
1 day
Change in Serum Level of BDNF After Ketamine Infusion
Periodo de tiempo: 1 day
changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.
1 day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jing Wang, MD, PHD, NYU School of Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2014

Finalización primaria (Actual)

13 de abril de 2017

Finalización del estudio (Actual)

13 de abril de 2017

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2015

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2015

Publicado por primera vez (Estimar)

22 de mayo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

2 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir