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

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).

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.

Study Overview

• Status: Completed
• Conditions: Incomplete Reversal of Neuromuscular Block; Postoperative Respiratory Complications
• Intervention / Treatment: Device: Accelerometry

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.

• Study Type: Observational
• Enrollment (Actual): 763

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Universitari
  • Castellón, Spain, 12004
    • Hospital General de Castellón
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Logroño, Spain, 26006
    • Hospital San Pedro
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28040
    • Hospital Fundacion Jimenez Diaz
  • Palma de Mallorca, Spain, 07010
    • Hospital Universitario Son Espases
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
  • Valencia, Spain, 46017
    • Hospital Universitario Dr Peset
  • Valencia, Spain, 46026
    • Hospital Universitario Politecnico La Fe
  • Zaragoza, Spain, 50009
    • Hospital Miguel Servet
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Hospital General de Elda
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
    • Badalona, Barcelona, Spain, 08907
      • Hospital De Bellvitge
  • Coruña
    • A Coruña, Coruña, Spain, 15006
      • Complejo Hospitalario Universitario
  • Madrid
    • Leganés, Madrid, Spain, 28911
      • Hospital Severo Ochoa
  • Palma de Mallorca
    • Manacor, Palma de Mallorca, Spain, 07500
      • Hospital de Manacor
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral de Vigo
  • Vizcaya
    • Basurto, Vizcaya, Spain, 48013
      • Hospital Universitario Basurto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients under general anesthesia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anesthesia; Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose	Device: Accelerometry; Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU; Other Names: TOF-Watch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU	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.	Upon arrival to the PACU. Single evaluation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory or airway postoperative complications in the PACU	Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.	During PACU stay, an expected average of 4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship of RNMB with preoperative patient related factors	Analysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics	Upon patients arrival to the PACU
Relationship of RNMB with intraoperative anesthesia-related factors	anesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.	Upon PACU arrival
Relationship of RNMB with surgery-related factors	Relationship 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.	Upon PACU arrival

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Hospital General Universitario Gregorio Marañon; General University Hospital of Valencia
• Investigators: Principal Investigator: Carlos L Errando, MD, PhD, Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia; Principal Investigator: Ignacio Garutti, MD, PhD, Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Muscle relaxants; Postoperative complications, respiratory; General anesthesia; Postanesthesia care unit; Neuromuscular block reversal
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: CEO-BNM-2014-01