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Effect of Neuromuscular Blockade and Reversal on Breathing (BREATH)

18 februari 2020 uppdaterad av: Albert Dahan, Leiden University Medical Center

Effect of Neuromuscular Blockade and Reversal by Sugammadex Versus Neostigmine on Breathing When Hypoxic or Hypercapnic in Volunteers

In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Studieöversikt

Detaljerad beskrivning

The carotid bodies, located at the bifurcation of the common carotid artery, play a crucial and life-saving role in the control of breathing in humans. The carotid bodies contain type 1 cells that are primarily sensitive to low oxygen concentrations in arterial blood. In response to low oxygen the carotid bodies send information to the brainstem respiratory centers and a brisk hyperventilatory response will be initiated ensuring an increase in uptake of oxygen via the lungs. Following surgery, a rapid return of the carotid body function is vital and persistent loss of carotid body function may result in respiratory complications that occur independent of the effects of anesthetics (incl. muscle relaxants) on respiratory muscles. Respiratory complications that are related to the loss of carotid body function include the inability to respond properly to hypoxia as well the inability to overcome upper airway obstruction. The latter is especially important in patients with sleep disordered-breathing and obese patients. These patients rely on the optimal function of their carotid bodies in response to hypoxia or upper airway closure.

Important neurotransmitters involved in the carotid body response to hypoxia include acetylcholine, which acts through local nicotinergic acetylcholine receptors. Apart from the observation that muscle relaxants (which are blockers of the acetylcholine receptors) affect the proper functioning of the carotid bodies, the investigators have no knowledge on the dynamic effects of muscle relaxants on carotid body function over time or on the relationship between carotid body function and Train-of-Four (TOF) ratio over time. Additionally, there is no data on the link between the use of NMB antagonists and return of carotid body function. Linking TOF ratio to carotid body function is of clinical importance as a possible relationship will allow clinicians to predict carotid body function from the TOF ratio. The latter is highly relevant as the investigators show in a previous trial that a large proportion of patients is extubated at TOF ratio's < 0.7.

Apart from the carotid bodies, chemoreceptors in the brainstem exist that are sensitive to hypercapnia. This response system is not under control of cholinergic neurotransmission. Since the investigators may assume that the hypercapnic ventilatory response is not influenced by muscle relaxants the investigators can use this response to calibrate the hypoxic ventilatory response as both responses are equally affected by the effect of muscle relaxants on muscle function.

As stated there is data on the effect of muscle relaxants on carotid body function at one fixed TOF ratio (TOF ratio fixed at 0.7). No data are available on:

  1. Dynamic effect of carotid body function as measured by the hypoxic ventilatory response at TOF ratio's slowly changing from 0.6 to 1.0;
  2. Dynamic effect of reversal of NMB by sugammadex versus neostigmine. Sugammadex and neostigmine are both reversal agents of neuromuscular blockade. At their institution the investigators use both agents in clinical practice but remain without knowledge on their effects on carotid body function. The current proposal is designed to study items 1 and 2 in healthy awake volunteers.

Studietyp

Interventionell

Inskrivning (Faktisk)

46

Fas

  • Fas 4

Kontakter och platser

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Studieorter

    • ZH
      • Leiden, ZH, Nederländerna, 2333 ZA
        • Leiden University Medical Center

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  • male gender
  • age 18 years and older
  • body mass index < 30 kg/m2.

Exclusion Criteria:

  • Known or suspected neuromuscular disorders impairing neuromuscular function;
  • allergies to muscle relaxants, anesthetics or narcotics;
  • a (family) history of malignant hyperthermia or any other muscle disease;
  • any medical, neurological or psychiatric illness (including a history of anxiety).

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: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: PLACEBO
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Andra namn:
  • Normal koksaltlösning
Övrig: NEOSTIGMINE
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Andra namn:
  • NEO
Experimentell: SUGAMMADEX
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Tidsram: during the 1-2 hours following reversal
The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia.
during the 1-2 hours following reversal
Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Tidsram: 0-10 minutes following reversal
The ventilatory response to a decrease in oxygen saturaytion of 80%
0-10 minutes following reversal

Samarbetspartners och utredare

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Publikationer och användbara länkar

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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 (Faktisk)

1 september 2016

Primärt slutförande (Faktisk)

1 september 2018

Avslutad studie (Faktisk)

1 september 2018

Studieregistreringsdatum

Först inskickad

14 juli 2016

Först inskickad som uppfyllde QC-kriterierna

26 juli 2016

Första postat (Uppskatta)

27 juli 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

We will publish the paper. After publication the data are available

Tidsram för IPD-delning

Mid 2019

Kriterier för IPD Sharing Access

Request to the authors and approved protocol for data analysis to be submitted. A review committee will then decide wether the data will be shared, deepening on supplementary data analyses by the authors

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