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Trial record 1 of 1 for:    NCT02698969
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Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography

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ClinicalTrials.gov Identifier: NCT02698969
Recruitment Status : Unknown
Verified October 2016 by Dr. Chiara Adembri, University of Florence.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Chiara Adembri, University of Florence

Brief Summary:
Diaphragm ultrasonography as a diagnostic tool in order to demonstrate the superiority of Sugammadex vs. AChEI in facilitating post-operative neuromuscular recovery.

Condition or disease Intervention/treatment Phase
Post-operative Residual Curarization Drug: Sugammadex Device: Diaphragm Ultrasonography Drug: Neostigmine Drug: Atropine Device: Neurumuscual monitoring Drug: Rocuronium Drug: Fentanyl Drug: Propofol Drug: Sevoflurane Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Recovery of Muscle Function After Deep Neuromuscular Block by Means of Dia-phragm Ultrasonography and Adductor Pollicis Acceleromyography: Comparison of Neostigmine vs. Sugammadex as Reversal Drugs.
Study Start Date : November 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Sugammadex
patients enrolled who will receive sugammadex 2 mg*kg-1 at the end of surgery
Drug: Sugammadex
Other Name: Bridion

Device: Diaphragm Ultrasonography
Prior to induction of anesthesia each enrolled patients, ultrasonography diaphragm evaluation will be performed using an ESAOTE ultrasound machine (ESAOTE MyLab, Genova, Italy) by assessing the TF and amplitude of excursion.
Other Name: Diaphragm Ultrasound

Device: Neurumuscual monitoring
Neuromuscular monitoring assesses muscle recovery after deep neuromuscular block through trainf of four and post tetanic count method
Other Name: Train of Four and post tetanic count

Drug: Rocuronium
Rocuronium will be administered 0.6 mg*kg-1 to reach neuromuscular block at the induction of general anesthesia and 0.15 mg*kg-1 when PTC elicits more than 5 twitches in order to maintain a deep neuromuscular block
Other Name: Esmeron

Drug: Fentanyl
Fentanest will be administered 2 mcg*kg-1 at the induction of general anesthesia and titrated 0.5 mcg*kg-1 every 30 minutes
Other Name: Fentanest

Drug: Propofol
Propofol will be administered 2 mg*kg-1 at the induction of general anesthesia
Other Name: Diprivan

Drug: Sevoflurane
Sevoflurane will be administered at 1.0 MAC in an air/oxygen mixture
Other Name: Sevorane

Active Comparator: Nestigmine, Atropine
patients enrolled who will receive neostigmine 50 mcg*kg-1 and atropine 15 mcg*kg-1 at the end of surgery
Device: Diaphragm Ultrasonography
Prior to induction of anesthesia each enrolled patients, ultrasonography diaphragm evaluation will be performed using an ESAOTE ultrasound machine (ESAOTE MyLab, Genova, Italy) by assessing the TF and amplitude of excursion.
Other Name: Diaphragm Ultrasound

Drug: Neostigmine
Other Name: Prostigmin

Drug: Atropine
Device: Neurumuscual monitoring
Neuromuscular monitoring assesses muscle recovery after deep neuromuscular block through trainf of four and post tetanic count method
Other Name: Train of Four and post tetanic count

Drug: Rocuronium
Rocuronium will be administered 0.6 mg*kg-1 to reach neuromuscular block at the induction of general anesthesia and 0.15 mg*kg-1 when PTC elicits more than 5 twitches in order to maintain a deep neuromuscular block
Other Name: Esmeron

Drug: Fentanyl
Fentanest will be administered 2 mcg*kg-1 at the induction of general anesthesia and titrated 0.5 mcg*kg-1 every 30 minutes
Other Name: Fentanest

Drug: Propofol
Propofol will be administered 2 mg*kg-1 at the induction of general anesthesia
Other Name: Diprivan

Drug: Sevoflurane
Sevoflurane will be administered at 1.0 MAC in an air/oxygen mixture
Other Name: Sevorane




Primary Outcome Measures :
  1. Number of participants with post-operative residual curarization (PORC) as assessed by diaphragm ultrasonography in order to determine its muscle strenght [ Time Frame: 30 minutes from the end of surgical procedure ]
    The clinician will assess TF (defined as a percentage) and amplitude of excursion (expressed in millimetres) of the diaphragm by means of ultrasonography


Secondary Outcome Measures :
  1. Number of participants with post-operative complications related to PORC such as pneumonia as assessed chest x ray, drop of SpO2 by means of pulse oximeter and blood gas sample. [ Time Frame: up to 1 week ]
  2. Number of participants with post-operative nausea and vomiting (PONV) as assessed by postoperative nause and vomiting visual analogic scale (PONV VAS) [ Time Frame: up to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-II
  • age between 18-80 years old
  • dNMB with rocuronium during ear nose and throat (ENT) surgery

Exclusion Criteria:

  • Clinical diagnosis of hepatic or renal disease
  • Clinical diagnosis of chronic or acute alcoholism
  • History of allergy or hypersensitivity to Sugammadex and/or atropine or Neostigmine
  • Current medications with CNS effects
  • History of neurologic disease
  • Diaphragmatic palsy
  • Pregnancy or nursing
  • History of malignant arrhythmias

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): NCT02698969


Contacts
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Contact: Chiara Adembri, MD +390554271101 chiara.adembri@unifi.it
Contact: Iacopo Cappellini, MD iacopo.cappellini@unifi.it

Locations
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Italy
Azienda Ospdaliero Universitaria Careggi Recruiting
Florence, Italy, 50134
Contact: Chiara Adembri, MD       chiara.adembri@unifi.it   
Contact: Iacopo Cappellini, MD       iacopo.cappellini@unifi.it   
Principal Investigator: Chiara Adembri, MD         
Sub-Investigator: Iacopo Cappellini, MD         
Sub-Investigator: Daniele Ostento, MD         
Sub-Investigator: Fabio Picciafuochi, MD         
Sponsors and Collaborators
University of Florence
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Chiara Adembri, MD University of Florence

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chiara Adembri, Medical Doctor, University of Florence
ClinicalTrials.gov Identifier: NCT02698969     History of Changes
Other Study ID Numbers: EUDRACT 2013-004-787-62
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Dr. Chiara Adembri, University of Florence:
Sugammadex
Post-operative residual curarization
Diaphragm Ultrasonography

Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Propofol
Fentanyl
Sevoflurane
Atropine
Rocuronium
Neostigmine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents