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Quality of Recovery After Reversal With Neostigmine or Sugammadex.

11 maj 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

80

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Stony Brook, New York, Förenta staterna, 11794
        • Stony Brook University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv 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.
Läkemedel: Neostigmine
Neostigmine will be given for reversal of neuromuscular blockade.
Andra namn:
  • Prostigmin
Aktiv komparator: Sugammadex
Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.
Läkemedel: Sugammadex
Sugammadex will be given for reversal of neuromuscular blockade.
Andra namn:
  • Bridion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Stony Brook University

Samarbetspartners

Merck Sharp & Dohme LLC

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2016

Primärt slutförande (Faktisk)

9 november 2017

Avslutad studie (Faktisk)

1 februari 2018

Studieregistreringsdatum

Först inskickad

31 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

16 september 2016

Första postat (Uppskatta)

21 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 maj 2020

Senast verifierad

1 maj 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 917402-3

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

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