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NCT Number: NCT02226809

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

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.

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Key information

Conditions

Incomplete Reversal of Neuromuscular Block Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Respiratory Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Elda, Elda, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerometry

Device

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

Other names: TOF-Watch

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • General University Hospital of Valencia
  • Hospital General Universitario Gregorio Marañon

Registry information

Official study 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).

Acronym: ReCuSS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2014
Registry last updated
Aug 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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