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

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ClinicalTrials.gov Identifier: NCT02226809
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Collaborators:
Valencia University General Hospital
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Carlos Luis Errando, Valencia University General Hospital

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.


Condition or disease Intervention/treatment
Incomplete Reversal of Neuromuscular Block Postoperative Respiratory Complications 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
Actual Enrollment : 763 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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 Name: TOF-Watch




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Respiratory or airway postoperative complications in the PACU [ Time Frame: 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.


Other Outcome Measures:
  1. Relationship of RNMB with preoperative patient related factors [ Time Frame: Upon patients arrival to the PACU ]
    Analysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics

  2. Relationship of RNMB with intraoperative anesthesia-related factors [ Time Frame: Upon PACU arrival ]
    anesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.

  3. Relationship of RNMB with surgery-related factors [ Time Frame: Upon PACU arrival ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical patients under general anesthesia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226809


Locations
Spain
Hospital General de Elda
Elda, Alicante, Spain, 03600
Hospital de Bellvitge
Badalona, Barcelona, Spain, 08907
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Complejo Hospitalario Universitario
A Coruña, Coruña, Spain, 15006
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital de Manacor
Manacor, Palma de Mallorca, Spain, 07500
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain, 36204
Hospital Universitario Basurto
Basurto, Vizcaya, Spain, 48013
Hospital Clinic Universitari
Barcelona, Spain, 08036
Hospital General de Castellón
Castellón, Spain, 12004
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital San Pedro
Logroño, Spain, 26006
Hospital Universitario Lucus Augusti
Lugo, Spain, 27003
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Universitario Son Espases
Palma de Mallorca, Spain, 07010
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Universitario Dr Peset
Valencia, Spain, 46017
Hospital Universitario Politécnico La Fe
Valencia, Spain, 46026
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
University of Valencia
Valencia University General Hospital
Hospital General Universitario Gregorio Marañon
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

Responsible Party: Carlos Luis Errando, MD, PhD, staff anesthesiologist, Valencia University General Hospital
ClinicalTrials.gov Identifier: NCT02226809     History of Changes
Other Study ID Numbers: CEO-BNM-2014-01
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by Carlos Luis Errando, Valencia University General Hospital:
Muscle relaxants
Postoperative complications, respiratory
General anesthesia
Postanesthesia care unit
Neuromuscular block reversal

Additional relevant MeSH terms:
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs