Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography

NCT02698969 | Unknown Phase 4 DMC

• 1 other identifier: EUDRACT 2013-004-787-62
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Residual Curarization

Keywords

Sugammadex; Post-operative residual curarization; Diaphragm Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Number of participants with post-operative residual curarization (PORC) as assessed by diaphragm ultrasonography in order to determine its muscle strenght

  The clinician will assess TF (defined as a percentage) and amplitude of excursion (expressed in millimetres) of the diaphragm by means of ultrasonography

  30 minutes from the end of surgical procedure

Secondary Outcomes (2)

• 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.

  up to 1 week

• Number of participants with post-operative nausea and vomiting (PONV) as assessed by postoperative nause and vomiting visual analogic scale (PONV VAS)

  up to 48 hours

Study Arms (2)

Sugammadex

EXPERIMENTAL

patients enrolled who will receive sugammadex 2 mg\*kg-1 at the end of surgery

Drug: Sugammadex; Device: Diaphragm Ultrasonography; Device: Neurumuscual monitoring; Drug: Rocuronium; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane

Nestigmine, Atropine

ACTIVE COMPARATOR

patients enrolled who will receive neostigmine 50 mcg\*kg-1 and atropine 15 mcg\*kg-1 at the end of surgery

Device: Diaphragm Ultrasonography; Drug: Neostigmine; Drug: Atropine; Device: Neurumuscual monitoring; Drug: Rocuronium; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane

Interventions

Sugammadex DRUG

Also known as: Bridion

Sugammadex

Diaphragm Ultrasonography DEVICE

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.

Also known as: Diaphragm Ultrasound

Nestigmine, Atropine; Sugammadex

Neostigmine DRUG

Also known as: Prostigmin

Nestigmine, Atropine

Atropine DRUG

Nestigmine, Atropine

Neurumuscual monitoring DEVICE

Neuromuscular monitoring assesses muscle recovery after deep neuromuscular block through trainf of four and post tetanic count method

Also known as: Train of Four and post tetanic count

Nestigmine, Atropine; Sugammadex

Rocuronium DRUG

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

Also known as: Esmeron

Nestigmine, Atropine; Sugammadex

Fentanyl DRUG

Fentanest will be administered 2 mcg\*kg-1 at the induction of general anesthesia and titrated 0.5 mcg\*kg-1 every 30 minutes

Also known as: Fentanest

Nestigmine, Atropine; Sugammadex

Propofol DRUG

Propofol will be administered 2 mg\*kg-1 at the induction of general anesthesia

Also known as: Diprivan

Nestigmine, Atropine; Sugammadex

Sevoflurane DRUG

Sevoflurane will be administered at 1.0 MAC in an air/oxygen mixture

Also known as: Sevorane

Nestigmine, Atropine; Sugammadex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Azienda Ospdaliero Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Related Publications (7)

• Viby-Mogensen J. Postoperative residual curarization and evidence-based anaesthesia. Br J Anaesth. 2000 Mar;84(3):301-3. doi: 10.1093/oxfordjournals.bja.a013428. No abstract available.

  PMID: 10793585 RESULT

• Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.

  PMID: 17307778 RESULT

• Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.

  PMID: 18385265 RESULT

• Wait JL, Nahormek PA, Yost WT, Rochester DP. Diaphragmatic thickness-lung volume relationship in vivo. J Appl Physiol (1985). 1989 Oct;67(4):1560-8. doi: 10.1152/jappl.1989.67.4.1560.

  PMID: 2676955 RESULT

• Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.

  PMID: 22476448 RESULT

• Cappellini I, Ostento D, Loriga B, Tofani L, De Gaudio AR, Adembri C. Comparison of neostigmine vs. sugammadex for recovery of muscle function after neuromuscular block by means of diaphragm ultrasonography in microlaryngeal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Jan;37(1):44-51. doi: 10.1097/EJA.0000000000001055.

  PMID: 31356374 DERIVED

• Cappellini I, Picciafuochi F, Ostento D, Danti G, De Gaudio AR, Adembri C. Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial. Trials. 2018 Feb 21;19(1):135. doi: 10.1186/s13063-018-2525-7.

  PMID: 29467022 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine; Atropine; Rocuronium; Fentanyl; Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Chiara Adembri, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Adembri, MD

CONTACT

+390554271101; chiara.adembri@unifi.it

Iacopo Cappellini, MD

CONTACT

iacopo.cappellini@unifi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: March 4, 2016
• Study Start: November 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

IT (1)