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

NCT02226809 | Completed

• 1 other identifier: CEO-BNM-2014-01
• Study Type: observational
• Target: 763
• Locations: 1 country
• Sites: 25

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.

Conditions

Incomplete Reversal of Neuromuscular Block; Postoperative Respiratory Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Respiratory or airway postoperative complications in the PACU

  During PACU stay, an expected average of 4 hours

Other Outcomes (3)

• Relationship of RNMB with preoperative patient related factors

  Upon patients arrival to the PACU

• Relationship of RNMB with intraoperative anesthesia-related factors

  Upon PACU arrival

• Relationship of RNMB with surgery-related factors

  Upon PACU arrival

Study Arms (1)

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

Interventions

Accelerometry DEVICE

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

Also known as: TOF-Watch

General anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients under general anesthesia

You may qualify if:

• Patients \>18 years-old
• General anesthesia with non-depolarizing NMBA
• Transferred extubated on spontaneous ventilation to the PACU

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead
• General University Hospital of Valencia: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (25)

Hospital General de Elda

Elda, Alicante, 03600, Spain

Location

Hospital de Bellvitge

Badalona, Barcelona, 08907, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic Universitari

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital General de Castellón

Castellon, Castellón, 12004, Spain

Location

Complejo Hospitalario Universitario

A Coruña, Coruña, 15006, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital de Manacor

Manacor, Palma de Mallorca, 07500, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Palma de Mallorca, 07010, Spain

Location

Hospital Xeral de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Universitario Dr Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Universitario Politécnico La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario Basurto

Basurto, Vizcaya, 48013, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Muscle Hypotonia; Postoperative Complications

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, staff anesthesiologist

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 27, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

ES (25)