Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit
NCT ID: NCT02226809
Last Updated: 2014-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
763 participants
OBSERVATIONAL
2014-06-30
2014-07-31
Brief Summary
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The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).
The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
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Detailed Description
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The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.
In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.
The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .
Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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General anesthesia
Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose
Accelerometry
Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
Interventions
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Accelerometry
Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General anesthesia with non-depolarizing NMBA
* Transferred extubated on spontaneous ventilation to the PACU
Exclusion Criteria
* emergency and cardiac surgery
* patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)
* noncompensated diabetes mellitus or diabetic neuropathy
* symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy
* chronic or acute renal insufficiency
* severe hepatopathy (Child-Pugh B, C)
* intraoperative blood transfusion \>3 blood units
* intraoperative maintained arterial hypotension
* arrival to the PACU intubated or with instrumented airway (including surgical)
* pre- or perioperative drugs intake affecting the neuromuscular transmission
* neuromuscular diseases affecting the physiology of the neuromuscular system
18 Years
ALL
No
Sponsors
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General University Hospital of Valencia
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
University of Valencia
OTHER
Responsible Party
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Carlos Luis Errando
MD, PhD, staff anesthesiologist
Principal Investigators
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Carlos L Errando, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia
Ignacio Garutti, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon
Locations
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Hospital General de Elda
Elda, Alicante, Spain
Hospital de Bellvitge
Badalona, Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic Universitari
Barcelona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General de Castellón
Castellon, Castellón, Spain
Complejo Hospitalario Universitario
A Coruña, Coruña, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital de Manacor
Manacor, Palma de Mallorca, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Palma de Mallorca, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Hospital Universitario Dr Peset
Valencia, Valencia, Spain
Hospital Universitario Politécnico La Fe
Valencia, Valencia, Spain
Hospital Universitario Basurto
Basurto, Vizcaya, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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CEO-BNM-2014-01
Identifier Type: -
Identifier Source: org_study_id
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