Clinical trial NCT02226809: Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit
Official title: Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incomplete Reversal of Neuromuscular Block
Postoperative Respiratory Complications
Keywords: Muscle relaxants
Postoperative complications, respiratory
General anesthesia
Postanesthesia care unit
Neuromuscular block reversal
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: General University Hospital of Valencia
name: Hospital General Universitario Gregorio Marañon
First posted: 2014-08-27
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients under general anesthesia

Brief summary: Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. 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 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.

Detailed description: Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.

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.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years-old
* General anesthesia with non-depolarizing NMBA
* Transferred extubated on spontaneous ventilation to the PACU

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV-V
* 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

Primary outcomes:
measure: Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
timeFrame: Upon arrival to the PACU. Single evaluation.
Secondary outcomes:
measure: Respiratory or airway postoperative complications in the PACU
timeFrame: During PACU stay, an expected average of 4 hours
Other outcomes:
measure: Relationship of RNMB with preoperative patient related factors
timeFrame: Upon patients arrival to the PACU
measure: Relationship of RNMB with intraoperative anesthesia-related factors
timeFrame: Upon PACU arrival
measure: Relationship of RNMB with surgery-related factors
timeFrame: Upon PACU arrival
Locations:
city: Elda
country: Spain
facility: Hospital General de Elda
state: Alicante
city: Badalona
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario
state: Coruña
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Manacor
country: Spain
facility: Hospital de Manacor
state: Palma de Mallorca
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
state: Pontevedra
city: Basurto
country: Spain
facility: Hospital Universitario Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr Peset
city: Valencia
country: Spain
facility: Hospital Universitario Politécnico La Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia
name: Carlos L Errando, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon
name: Ignacio Garutti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: