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Clinical Trials/NCT02226809
NCT02226809
Completed
Not Applicable

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).

University of Valencia25 sites in 1 country763 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incomplete Reversal of Neuromuscular Block
Sponsor
University of Valencia
Enrollment
763
Locations
25
Primary Endpoint
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
July 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlos Luis Errando

MD, PhD, staff anesthesiologist

General University Hospital of Valencia

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)

Outcomes

Primary Outcomes

Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU

Time Frame: 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 Outcomes

  • Respiratory or airway postoperative complications in the PACU(During PACU stay, an expected average of 4 hours)

Study Sites (25)

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