Quality of Recovery After Reversal With Neostigmine or Sugammadex.
Pulmonary Function, Muscle Strength, Time to Extubation and Quality of Recovery in the Post Anesthesia Care Unit After Reversal of Neuromuscular Blockade With Neostigmine or Sugammadex.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sugammadex has been shown to have a faster onset and more reliable reversal of neuromuscular blockade when compared to neostigmine as measured by return of Train-of-four (TOF) ratio to >0.9. (Breuckmann, 2015) The investigator's hypothesis is that sugammadex will be associated with improved deep breathing as measured by incentive spirometry in the PACU. The investigators also hypothesize that patients reversed with sugammadex will have shorter times to extubation and better recovery profiles in the PACU as measured by strength, PACU discharge readiness and quality of recovery scores.
Residual neuromuscular blockade after surgery can result in airway compromise, pulmonary complications, and possible need for reintubation and can be a negative experience for patients. Reintubation after surgery is currently a quality measure in NSQIP (National Surgery Quality Improvement Program) A TOF ratio of <0.9 has been identified as a marker of residual neuromuscular blockade in the PACU. (Farhan 2013) Several clinical trials have shown that reversal of neuromuscular blockade with sugammadex results in a faster and more reliable return to TOF ratio of >0.9 when compared to neostigmine. However most of these studies primarily report on TOF ratios. There are scant data on clinical outcomes after reversal with neostigmine versus sugammadex. Incentive spirometry is a clinically meaningful measurement of postoperative pulmonary function, i.e the ability to breath deeply, which minimizes atelectasis and risk of postoperative pneumonia.
The investigators will compare recovery profiles of patients who have received sugammadex or neostigmine for reversal of neuromuscular blockade after surgery. The primary outcome will be incentive spirometry volumes after surgery as a measure of pulmonary function. The secondary measures include hand grip measured using a dynamometer, time to extubation, time to PACU discharge, time to sit independently, and quality of recovery 15 survey scores.
This will be a single-center, prospective, randomized, assessor blinded, controlled trial. Patients will be randomized to either receive sugammadex or neostigmine for the reversal of neuromuscular blockade. The anesthesiologist will be unblinded to the study drug however the assessor in the PACU will be blinded.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant must be willing and able to provide written informed consent for the study
- Participant must be greater than or equal to 18 years of age
- Participant must be ASA (American Society of Anesthesiologists) class I, II or III
- Planned use of neuromuscular blocking drugs
- Planned use of endotracheal intubation
- Planned for extubation to occur in the OR
Exclusion Criteria:
- ASA (American Society of Anesthesiologists) Class IV
- Age < 18 years old
- Inability to give oral or written consent
- Known or suspected neuromuscular disorder impairing neuromuscular function
- True allergy to muscle relaxants
- A (family) history of malignant hyperthermia
- A contraindication for neostigmine or sugammadex administration
- Serum creatinine level of greater than 2.0 mg/dL
- Surgery where the patient's arm is not available for neuromuscular monitoring
- A plan to extubate under deep anesthesia
- Pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Neostigmine
Patients in this arm will receive neostigmine for reversal of neuromuscular blockade.
Neostigmine is historically the medication that has been used for this purpose.
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Neostigmine will be given for reversal of neuromuscular blockade.
Otros nombres:
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Comparador activo: Sugammadex
Patients in this arm will receive sugammadex for reversal of neuromuscular blockade.
Sugammadex is a newer, FDA approved, medication for this purpose.
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Sugammadex will be given for reversal of neuromuscular blockade.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Periodo de tiempo: 30 Minutes
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Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery.
The change from baseline and recovery profile will be measured.
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30 Minutes
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Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
Periodo de tiempo: 60 Minutes after reversal
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Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery.
The change from baseline and recovery profile will be measured.
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60 Minutes after reversal
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Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
Periodo de tiempo: 120 minutes after reversal
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Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery.
The change from baseline and recovery profile will be measured.
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120 minutes after reversal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Grip Strength, Change From Baseline and Recovery Profile 30 Min
Periodo de tiempo: 30 minutes
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Grip strength will be measured with a hand dynamometer
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30 minutes
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Grip Strength, Change From Baseline and Recovery Profile 60 Min
Periodo de tiempo: 60 minutes after reversal
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Grip strength will be measured with a hand dynamometer
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60 minutes after reversal
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Grip Strength, Change From Baseline and Recovery Profile 120 Min
Periodo de tiempo: 120 minutes after surgery
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Grip strength will be measured with a hand dynamometer
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120 minutes after surgery
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Time to Extubation
Periodo de tiempo: Immediately after surgery, up to 30 minutes
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Measured time between surgery end and time of extubation (removal of breathing tube)
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Immediately after surgery, up to 30 minutes
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Train of Four Ratio > 90% During PACU Admission
Periodo de tiempo: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
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Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation.
This measurement was performed using a TOF Watch, which in an accelemyographer.
Electric current is applied to the ulnar nevre and the twitches are measured in the thumb.
Adequate reversal of neuromuscular blockade is defined as a TOFR >90%.
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At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
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Quality of Recovery 15 Survey
Periodo de tiempo: Postoperative day number one
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15 question survey to assess patient's overall quality of recovery after anesthesia/surgery. Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery. Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc. Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc. |
Postoperative day number one
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Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
Periodo de tiempo: Within 4 hours from the end of surgery
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Measured time between PACU admission and meeting PACU discharge readiness.
PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse.
The Aldrete score is a measure of post anesthesia recovery.
0 is poor condition and 10 is excellent condition.
There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent.
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Within 4 hours from the end of surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ramon Abola, MD, Stony Brook Medicine, Department of Anesthesiology
Publicaciones y enlaces útiles
Publicaciones Generales
- Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.
- Farhan H, Moreno-Duarte I, McLean D, Eikermann M. Residual Paralysis: Does it Influence Outcome After Ambulatory Surgery? Curr Anesthesiol Rep. 2014 Dec;4(4):290-302. doi: 10.1007/s40140-014-0073-6.
- Abola RE, Romeiser J, Rizwan S, Lung B, Gupta R, Bennett-Guerrero E. A randomized-controlled trial of sugammadex versus neostigmine: impact on early postoperative strength. Can J Anaesth. 2020 Aug;67(8):959-969. doi: 10.1007/s12630-020-01695-4. Epub 2020 May 13.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 917402-3
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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