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Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit

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).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02226809
Acronym
ReCuSS
Enrollment
763
Registered
2014-08-27
Start date
2014-06-30
Completion date
2014-07-31
Last updated
2014-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incomplete Reversal of Neuromuscular Block, Postoperative Respiratory Complications

Keywords

Muscle relaxants, Postoperative complications, respiratory, General anesthesia, Postanesthesia care unit, Neuromuscular block reversal

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.

Interventions

Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU

Sponsors

General University Hospital of Valencia
CollaboratorOTHER
Hospital General Universitario Gregorio Marañon
CollaboratorOTHER
University of Valencia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACUUpon 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

MeasureTime frameDescription
Respiratory or airway postoperative complications in the PACUDuring PACU stay, an expected average of 4 hoursEvaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.

Other

MeasureTime frameDescription
Relationship of RNMB with preoperative patient related factorsUpon patients arrival to the PACUAnalysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics
Relationship of RNMB with intraoperative anesthesia-related factorsUpon PACU arrivalanesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.
Relationship of RNMB with surgery-related factorsUpon PACU arrivalRelationship of RNMB with surgery related factors (surgical speciality, type of surgery -high risk vs low to intermedium risk, laparoscopic vs no laparoscopic-, duration), blood losses.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026