Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit
- Conditions
- Incomplete Reversal of Neuromuscular BlockPostoperative Respiratory Complications
- Interventions
- Device: Accelerometry
- Registration Number
- NCT02226809
- Lead Sponsor
- University of Valencia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 763
- Patients >18 years-old
- General anesthesia with non-depolarizing NMBA
- Transferred extubated on spontaneous ventilation to the PACU
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description General anesthesia Accelerometry Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose
- Primary Outcome Measures
Name Time Method Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU Upon arrival to the PACU. Single evaluation. Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated.
The evaluator does'nt know the patient-related information, including intraoperative management.
- Secondary Outcome Measures
Name Time Method Respiratory or airway postoperative complications in the PACU During PACU stay, an expected average of 4 hours Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.
Trial Locations
- Locations (25)
Hospital General de Elda
🇪🇸Elda, Alicante, Spain
Hospital de Bellvitge
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Xeral de Vigo
🇪🇸Vigo, Pontevedra, Spain
Hospital Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario Basurto
🇪🇸Basurto, Vizcaya, Spain
Hospital General de Castellón
🇪🇸Castellón, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Politécnico La Fe
🇪🇸Valencia, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Reina SofÃa
🇪🇸Córdoba, Spain
Hospital Clinic Universitari
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario Dr Peset
🇪🇸Valencia, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Complejo Hospitalario Universitario
🇪🇸A Coruña, Coruña, Spain
Hospital de Manacor
🇪🇸Manacor, Palma de Mallorca, Spain