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Quality of Recovery After Reversal With Neostigmine or Sugammadex.

11. Mai 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • Stony Brook, New York, Vereinigte Staaten, 11794
        • Stony Brook University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 99 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Arzneimittel: Neostigmine
Neostigmine will be given for reversal of neuromuscular blockade.
Andere Namen:
  • Prostigmin
Aktiver Komparator: Sugammadex
Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.
Arzneimittel: Sugammadex
Sugammadex will be given for reversal of neuromuscular blockade.
Andere Namen:
  • Braution

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Grip Strength, Change From Baseline and Recovery Profile 30 Min
Zeitfenster: 30 minutes
Grip strength will be measured with a hand dynamometer
30 minutes
Grip Strength, Change From Baseline and Recovery Profile 60 Min
Zeitfenster: 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
Zeitfenster: 120 minutes after surgery
Grip strength will be measured with a hand dynamometer
120 minutes after surgery
Time to Extubation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stony Brook University

Mitarbeiter

Merck Sharp & Dohme LLC

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2016

Primärer Abschluss (Tatsächlich)

9. November 2017

Studienabschluss (Tatsächlich)

1. Februar 2018

Studienanmeldedaten

Zuerst eingereicht

31. August 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. September 2016

Zuerst gepostet (Schätzen)

21. September 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2020

Zuletzt verifiziert

1. Mai 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 917402-3

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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