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

Postoperative Respiratory Complications Clinical Trial

— ReCuSS  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226809
• Other study ID #: CEO-BNM-2014-01
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: August 26, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Incomplete Reversal of Neuromuscular Block
• Postoperative Respiratory Complications

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario	A Coruña	Coruña
Spain	Hospital de Bellvitge	Badalona	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic Universitari	Barcelona
Spain	Hospital Universitario Basurto	Basurto	Vizcaya
Spain	Hospital General de Castellón	Castellón
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital General de Elda	Elda	Alicante
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital San Pedro	Logroño
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital de Manacor	Manacor	Palma de Mallorca
Spain	Hospital Universitario Son Espases	Palma de Mallorca
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr Peset	Valencia
Spain	Hospital Universitario Politécnico La Fe	Valencia
Spain	Hospital Xeral de Vigo	Vigo	Pontevedra
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Hospital General Universitario Gregorio Marañon, Valencia University General Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Other	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	Yes
Primary	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.	Yes
Secondary	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	Yes