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Quality of Recovery After Reversal With Neostigmine or Sugammadex.

11 mai 2020 mis à jour par: Ramon Abola, Stony Brook University

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.

This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

80

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • Stony Brook, New York, États-Unis, 11794
        • Stony Brook University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: Neostigmine
Neostigmine will be given for reversal of neuromuscular blockade.
Autres noms:
  • Prostigmine
Comparateur actif: Sugammadex
Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.
Médicament: Sugammadex
Sugammadex will be given for reversal of neuromuscular blockade.
Autres noms:
  • Bridion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Délai: 30 Minutes
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
30 Minutes
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
Délai: 60 Minutes after reversal
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
60 Minutes after reversal
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
Délai: 120 minutes after reversal
Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
120 minutes after reversal

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Grip Strength, Change From Baseline and Recovery Profile 30 Min
Délai: 30 minutes
Grip strength will be measured with a hand dynamometer
30 minutes
Grip Strength, Change From Baseline and Recovery Profile 60 Min
Délai: 60 minutes after reversal
Grip strength will be measured with a hand dynamometer
60 minutes after reversal
Grip Strength, Change From Baseline and Recovery Profile 120 Min
Délai: 120 minutes after surgery
Grip strength will be measured with a hand dynamometer
120 minutes after surgery
Time to Extubation
Délai: Immediately after surgery, up to 30 minutes
Measured time between surgery end and time of extubation (removal of breathing tube)
Immediately after surgery, up to 30 minutes
Train of Four Ratio > 90% During PACU Admission
Délai: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
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%.
At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.
Quality of Recovery 15 Survey
Délai: Postoperative day number one

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
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
Délai: Within 4 hours from the end of surgery
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.
Within 4 hours from the end of surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Stony Brook University

Collaborateurs

Merck Sharp & Dohme LLC

Les enquêteurs

  • Chercheur principal: Ramon Abola, MD, Stony Brook Medicine, Department of Anesthesiology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2016

Achèvement primaire (Réel)

9 novembre 2017

Achèvement de l'étude (Réel)

1 février 2018

Dates d'inscription aux études

Première soumission

31 août 2016

Première soumission répondant aux critères de contrôle qualité

16 septembre 2016

Première publication (Estimation)

21 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 917402-3

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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