Residual neuromuscular blockade and diphragm fatigue
Conditions
Interventions
Trade Name: Bridion
Product Name: Bridion
Pharmaceutical Form: Injection
INN or Proposed INN: SUGAMMADEX
Other descriptive name: SUGAMMADEX
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Universitair Ziekenhuis Antwerpen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each participant must have the mental capacity to decide whether he/she takes part in the trial or not. Each participant must voluntarily give his/her written informed consent. In case a participant is physically unable to give a written informed consent, a legal representative is to perform this. Each participant must be at least 18 years of age. Participants can be of either sex and of any ethnical background. Each participant must meet the American Society of Anaesthesiologists class I, II or III criteria. Each participant must be scheduled for intracranial surgery. During general anaesthesia rocuronium must be used as a neuromuscular blocking agent. Each participant must be a suitable candidate for the rapid reversal of the neuromuscular blockade. Each female participant of sexually active age and of childbearing potential must agree to the use of a medically accepted method of contraception through 7 days after the day of surgery. Postmenopausal (defined as at least 12 consecutive months without spontaneous menstrual period) women are not obliged to use contraceptives. Medically accepted methods of contraception include: Condoms (male or female) with spermicidal agent. Diaphragms or cervical caps containing a spermicidal agent. Medically prescribed intrauterine devices (IUD’s). Inert or copper-containing IUD’s. Surgical sterilization (hysterectomy or tubal ligation). Hormonal contraceptives. (If a dose is missed on the day of the operation, participants must follow the instructions mentioned on the package leaflet. In case of a non-oral hormonal contraceptive, an additional non-hormonal contraceptive method is to be used). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: The participant is known or suspected to have a neuromuscular disorder. The participant is known or suspected to have an allergic reaction to sugammadex, rocuronium, anaesthetic and narcotic medications, or any of their excipients/recipients. The participant is known or suspected to have an anatomical malformation impeding a proper intubation. The participant is known or suspected to have a history of malignant hyperthermia. The participant is pregnant (or intends to become pregnant within the pre-surgical period) or lactating. The participant is known to have a renal insufficiency (defined as a serum creatinine concentration of two times the upper limit, or a glomerular filtration rate of less than 60 ml/min, a urine output of less than 0.5 ml/kg/h for at least six hours, an estimated creatinine clearance of less than 30 ml/min). The participant is known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher. The participant is known to have an infection of the upper or lower airways, as diagnosed by clinical, radiographic or laboratory findings. The participant is known or suspected to have congestive heart failure. The participant is known or suspected to have a psychiatric illness inhibiting his/her cooperation with the study protocol or possibly obscuring the obtained results. The participant is obese, as defined by a body mass index of 30 kg/m2 or more. The participant is known or suspected to have a major hepatic dysfunction preventing his partaking in the trial (as determined by the investigator). The participant has received or is scheduled to receive toremifene and/or an intravenous administration of fusidic acid within a time span of 24 hours before and 24 hours after the surgery. The participant is known or suspected to have any condition contraindicating the administration of sugammadex, neostigmine or glycopyrrolate. The participant is known or suspected to be directly involved in this study and/or is employed by or is a family member of any person employed by the investigator, at the investigational site or by the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Respiratory event endpoints Events that occur within the first hour after extubation are of primary concern, because these may be linked to diaphragmatic weakness, recurring neuromuscular blockade or weaning strategies. The respiratory events recorded will be desaturation <90% (SpO2 <90) and need for re-intubation.;Timepoint(s) of evaluation of this end point: One hour after extubation;Main Objective: The effect of sugammadex on diaphragmatic activity during end-of-surgery weaning (as registered on EMG, arterial blood gas, respiratory events), in comparison with routine practice (neostigmine or spontaneous reversal) ;Secondary Objective: Assessment of typical diaphragmatic activity during invasive ventilation using the Dipha-16 monitor. The effect of NMBAs and invasive ventilation on diaphragmatic function as measured through the Edi signal obtained with the Dipha-16 monitor. The effect of a deep NMB and high dose sugammadex on diaphragmatic activity during end-of-surgery weaning (as registered on EMG, arterial blood gas, respiratory events) Ease-of-use of EMG monitoring in a perioperative setting. Degree of muscle fatigue after single dose, repeated doses or continuous infusion of rocuronium. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints Anaphylaxis and anaphylactic reactions have been reported to occur with sugammadex. All suspected allergic reactions will be registered and referred for further workup.;Timepoint(s) of evaluation of this end point: As from IMP adminstration till 24 hours after extubation | — |
Countries
Belgium
Contacts
Public ContactDienst anesthesiologie
Universitair Ziekenhuis Antwerpen
Outcome results
None listed