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Trial record 71 of 186 for:    GLYCOPYRROLATE

Electromyographic Activity of the Respiratory Muscles During Neostigmine or Sugammadex Enhanced Recovery After Neuromuscular Blockade (REDNESII)

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ClinicalTrials.gov Identifier: NCT02403063
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital

Brief Summary:
It was recently shown that neostigmine reversal was associated with increased atelectasis and that high-dose neostigmine was associated with longer postoperative length of stay and with an increased incidence of pulmonary edema and reintubation. These study results were consistent with findings from a previous epidemiological study which revealed an absence of beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This could be explained by a possible effect on neuromuscular transmission at the muscle level, but can also be explained by a neostigmine-induced decrease in total nerve activity. In a study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The investigators aim to show a difference in phrenic nerve activity between neostigmine and sugammadex, administered alone or in combination, in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Respiratory Muscles Electromyography Drug: Sugammadex Drug: Neostigmine Drug: Neostigmine-sugammadex Phase 4

Detailed Description:

An auxiliary surface EMG will be recorded via ordinary skin electrodes at the diaphragm, and intercostal and rectus abdominis muscles. The degree of neuromuscular blockade is continuously measured by accelerometry of the adductor pollicis muscle with ulnar nerve stimulation (TOF-watch SX®). Anesthesia is induced with propofol and remifentanil. Manually assisted ventilation with an air/oxygen mixture of 40% oxygen is started as soon as patients are becoming apnoeic. Train-of-four (TOF) monitoring starts after the induction of anesthesia (before rocuronium administration) and continues until awakening. The investigators will insert a 16 Fr. nasogastric catheter which allows electrical activity of the diaphragm (Edi) registration (NAVA, Maquet, Solna, Sweden). After baseline measurements, 0.6 mg/kg rocuronium is injected. After tracheal intubation, subjects will be ventilated by a standard ventilation mode (tidal volume 7 ml/kg, frequency of 12 breaths per minute, inspired oxygen fraction of 30%), with end-tidal PCO2 targets of 30-35 mmHg and a PEEP of 5 cmH2O. SpO2 values will be maintained at ≥98%. Spontaneous recovery is allowed to progress until the re-appearance of the second twitch of the TOF. The volunteers will then receive either sugammadex 2mg/kg or neostigmine 50µg/kg + glycopyrrolate 10µg/kg (using the commercially available 5:1 co-formulation) or neostigmine 50µg/kg followed 3 minutes later by administration of sugammadex 2mg/kg. At the onset of spontaneous respiration, an arterial blood gas sample will be drawn. NAVA catheter positioning will be confirmed using the 'Edi catheter positioning' tool as soon as a signal is received. A second arterial blood gas sample will be drawn at the moment of awakening.

Diaphragm electromyographic activity (Edi, obtained from the NAVA catheter), airway pressure and flow are acquired at 100 Hz from the ventilator via an interface connected to a computer using commercially available software (Maquet Critical Care, Solna, Sweden). The auxiliary surface EMG will be recorded with a dedicated device (Dipha16, InBiolab, Groningen, The Netherlands) at the diaphragm, and intercostal and rectus abdominis muscles. All data will be stored and later analysed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Electromyographic Activity of the Diaphragm and of the Rectus Abdominis and Intercostal Muscles During Neostigmine, Sugammadex, or Neostigmine-sugammadex Enhanced Recovery After Neuromuscular Blockade With Rocuronium. A Randomised Controlled Study in Healthy Volunteers
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sugammadex
Selective relaxant binding agent
Drug: Sugammadex
Administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium
Other Name: Bridion

Active Comparator: neostigmine
Acetylcholinesterase inhibitor
Drug: Neostigmine
Administration of neostigmine 50µg/kg for enhanced recovery after neuromuscular blockade with rocuronium
Other Name: Robinul-neostigmine

Experimental: neostigmine-sugammadex
Acetylcholinesterase inhibitor followed by a selective relaxant binding agent
Drug: Neostigmine-sugammadex
Administration of neostigmine 50µg/kg followed 3 minutes later by administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium




Primary Outcome Measures :
  1. Electromyographic activity of the respiratory muscles during recovery enhanced by sugammadex, neostigmine or neostigmine followed by sugammadex [ Time Frame: Participants will be followed from administration of study drug until tracheal extubation, an expected average of 1 hour ]
    EMG activity of the diaphragm (EMGdi), and of the rectus abdominis and of the intercostal muscles during recovery enhanced by sugammadex 2mg/kg or neostigmine 50µg/kg or neostigmine 50µg/kg followed 3 minutes later by administration of sugammadex 2mg/kg


Secondary Outcome Measures :
  1. Tidal volume of breaths recorded by the ventilator [ Time Frame: Participants will be followed from administration of study drug until tracheal extubation, an expected average of 1 hour ]
  2. The partial pressure of O2 and of carbon dioxide in arterial blood [ Time Frame: Participants will be followed from administration of study drug until tracheal extubation, an expected average of 1 hour ]
  3. The arterial oxygen saturation [ Time Frame: Participants will be followed from induction of anesthesia until two hours after extubation of the trachea, an expected average of 3 hours ]
    Saturation of hemoglobin with oxygen as measured by Pulse Oximetry



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Only male, healthy volunteers will be enrolled after an in-depth interview.
  • Each participant must have the mental capacity to decide whether he takes part in the trial or not. Each participant must voluntarily give his written informed consent.
  • Each participant must be between 18 and 40 years of age.
  • Each participant must meet the American Society of Anaesthesiologists class I 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 medications, or any drugs used during general anaesthesia.
  • 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 known to have a renal insufficiency .
  • 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 findings.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403063


Locations
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Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: GUY CAMMU, MD, PhD OLV Hospital, Aalst, Belgium

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy CAMMU, MD, PhD, Anesthesiologist, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT02403063     History of Changes
Other Study ID Numbers: TSGC03
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents