Postoperative Residual Curarisation at Arrival in the Post-anesthesia Care Unit

NCT01362647 | Completed

• 2 other identifiers: B126201110617IISP ID 39443
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have documented that neuromuscular block often persists in the postanesthesia care unit (PACU). Residual paralysis is associated with postoperative complications such as hypoxia, weakness, and respiratory failure. The data in the current literature on residual paralysis in the PACU were almost exclusively obtained with acetylcholinesterase inhibitors as they were the only reversal agents available prior to the introduction in clinical practice of sugammadex (Bridion®) in the European Union and in some other countries, except for the USA. Reassessment of practice in this regard is relevant, now that sugammadex (Bridion®) has become available in our country since 2009. This study is an observational/non-interventional, non-randomized study involving adult patients undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking drugs (NMBDs). Administration of NMBDs and reversal agents (as well as all drugs which will be used during anesthesia) will be performed in accordance with routine anesthetic practice. The study population will comprise about 600 surgical patients. Immediately after the patients' arrival in the PACU, a study nurse will record the acceleromyographic responses of their adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve. A TOF of 90% will be used as cut-off value to exclude residual paralysis. Pulse oximetry (SpO2) will be measured continuously throughout the PACU admission, and SpO2 values will be recorded at 1-min intervals for the first 30 min. PACU nurses caring for the patient will document the occurrence of any of the following events during the first 30 min of PACU admission: the number of episodes of hypoxemia (SpO2\<90%), the lowest SpO2 observed by nursing staff, the requirement for either tactile or verbal stimulation to maintain SpO2 greater than 90%, and any clinical evidence of airway obstruction. The primary objective is to evaluate the incidence of postoperative residual curarisation at PACU arrival in patients reversed with sugammadex (Bridion®), neostigmine and in case of spontaneous recovery. The secondary objectives are to evaluate:

• Oxygen saturation (SpO2) at PACU arrival
• Possible episodes of SpO2 \<90% in the PACU
• Airway maneuvers and/or stimulation required to maintain SpO2 \>90% in the PACU
• Need for re-intubation.

Conditions

Postoperative Residual Curarisation; Postoperative Hypoxemia; Postoperative Airway Obstruction

Keywords

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative residual curarisation

  incidence of postoperative residual curarisation (PORC) defined by a train-of-four (TOF) ratio \< 0,9 at post-anesthesia care unit (PACU) arrival

  Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded.

Secondary Outcomes (3)

• Possible episodes of SpO2 <90% in the PACU

  During the first 30 min of PACU admission

• Airway maneuvers and/or stimulation required to maintain SpO2 >90% in the PACU

  During the first 30 min of PACU admission

• Need for re-intubation

  During the first 30 min of PACU admission

Interventions

neuromuscular transmission monitoring PROCEDURE

The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of TOF-Watch®, Organon Ireland Ltd., a division of MSD, Swords, Co., Dublin, Ireland.

Pulse oximetry measurement PROCEDURE

Pulse oximetry will be measured continuously throughout the PACU admission, and SpO2 values will be recorded at 1-min intervals for the first 30 min.

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

The study population will comprise about 600 surgical patients (the first 600 inpatients and outpatients scheduled for anesthesia during the study period who meet the study criteria).

You may qualify if:

• years of age or older;
• Informed consent signed;
• Admission for elective surgery;
• Administration of non-depolarizing NMBDs during surgery;
• Tracheal intubation

You may not qualify if:

• Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders
• Ejection fraction \<20%
• Admission for emergency surgery; or cardiothoracic surgery
• Reoperation during the same hospital admission

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

OLV Hospital

Aalst, 9300, Belgium

Location

Related Publications (1)

• Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.

  PMID: 16428537 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Cammu, MD, PhD

  OLV Hospital, Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: May 30, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

BE (1)