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Neuromuscular Blockade on Shoulder Pain of Elderly

11 de noviembre de 2020 actualizado por: M.D. Anderson Cancer Center

The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial

Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP.

In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon.

To reverse the effects of NMB after surgery, a drug called neostigmine is given.

The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given.

This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no one knows if one group is better, the same, or worse than the other.

  • In Group 1, you will receive deep NMB and Sugammadex.
  • In Group 2, you will receive moderate NMB and neostigmine.

Neither you nor the surgeon or surgical staff will know to which group you have been assigned. The surgeon will not know which group you are in because researchers want to learn how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery. However, if needed for your safety, the surgeon will be able to find out which group you are in.

For your safety, the anesthesiologist will know to which group you have been assigned.

Surgery and Study Drug Administration:

After you have been assigned to a study group, you will have your surgery as scheduled. You will sign a separate consent form for surgery which describes the procedure and its risks in more detail. You will also sign a separate consent form to receive anesthesia.

Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to the status of the disease and/or your reaction to the study drug(s).

During the surgery, the insufflation pressure that is being used, including any changes that are made to the pressure, will be recorded. After the surgery has been completed, you will receive either Sugammadex or neostigmine by vein until the effects of the NMB have been reversed.

You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and 90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are feeling and if so, how intense the pain is. Information about how long you stay in the hospital after surgery and if you have any side effects after surgery (such as nausea/vomiting or shoulder pain) will also be collected from your medical record.

Follow-Up:

After 30 days after you leave the hospital, you will be called by a member of the study staff to ask how you are doing and if you have had any additional hospitalizations since leaving the hospital. This phone call should last about 5-10 minutes.

Length of Study Participation:

Your participation in this study will be over after completing the 30-day follow up phone call.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

Fase

  • Fase 4

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

  • Estados Unidos
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • University of Texas MD Anderson Cancer 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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Patients 65 years of age or older
  2. Patients having robotic prostatectomy
  3. Written informed consent

Exclusion Criteria:

  1. Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
  2. Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
  3. Patients with history of severe liver disease, defined as and confirmed by elevated ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less than 3 OR INR 1.5 or greater per institutional laboratory.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Deep Neuromuscular Blockade (NMB) + Sugammadex

Deep Neuromuscular Blockade (NMB) given during surgery.

Sugammadex intravenously as a single bolus injection after surgery.

Pain assessment done at about 15, 45, and 90 minutes after surgery.
Droga: Deep Neuromuscular Blockade (NMB)
Deep Neuromuscular Blockade (NMB) given during surgery.
Droga: Sugammadex
4 mg/Kg, intravenously as a single bolus injection after surgery.
Conductual: Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Otros nombres:
  • Encuesta
Experimental: Moderate Neuromuscular Blockade (NMB) + Neostigmine

Moderate Neuromuscular Blockade (NMB) given during surgery.

Neostigmine intravenously slowly over a period of at least 1 minute after surgery.

Pain assessment done at about 15, 45, and 90 minutes after surgery.
Conductual: Pain Assessment
Pain assessment done at about 15, 45, and 90 minutes after surgery.
Otros nombres:
  • Encuesta
Droga: Moderate Neuromuscular Blockade (NMB)
Moderate Neuromuscular Blockade (NMB) given during surgery.
Droga: Neostigmine
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients Who Reported Shoulder Pain
Periodo de tiempo: 30 days
Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.
30 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative Intraoperative Insufflation Pressure
Periodo de tiempo: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.
Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
Periodo de tiempo: Day 0 - Arrival time at PACU, an average of 3 minutes
The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.
Day 0 - Arrival time at PACU, an average of 3 minutes
Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
Periodo de tiempo: Assessed at 15, 45, 90 minutes during PACU stay.
Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%. 2:85%≤ SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP< 100mmHg.2:80mmHg≤SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50<HR≤100.1:100<HR≤120.2:40<HR≤ 50 or 120<HR≤130.3:HR<40 or HR>130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting.
Assessed at 15, 45, 90 minutes during PACU stay.
Percentage of Participants With Nausea and/or Vomiting in PACU
Periodo de tiempo: Day 0 - PACU stay, an average of 120 minutes
Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).
Day 0 - PACU stay, an average of 120 minutes
Surgical Exposure Grading
Periodo de tiempo: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
Length of Hospital Stay
Periodo de tiempo: length of hospital stay(average of 3 days)
length of hospital stay(average of 3 days)

Colaboradores e Investigadores

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

Patrocinador

M.D. Anderson Cancer Center

Colaboradores

Merck Sharp & Dohme LLC

Investigadores

  • Investigador principal: Wendell H. Williams III, MD, M.D. Anderson Cancer Center

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.

Publicaciones Generales

Enlaces Útiles

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)

17 de noviembre de 2017

Finalización primaria (Actual)

30 de septiembre de 2018

Finalización del estudio (Actual)

22 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

29 de junio de 2017

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2017

Publicado por primera vez (Actual)

6 de julio de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de noviembre de 2020

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

11 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2017-0046 (Otro identificador: Institutional Review Board)
  • NCI-2018-01176 (Identificador de registro: NCI CTRP)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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. .

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