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

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ClinicalTrials.gov Identifier: NCT01362647
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : October 5, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Onze Lieve Vrouw Hospital

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.

Condition or disease Intervention/treatment
Postoperative Residual Curarisation Postoperative Hypoxemia Postoperative Airway Obstruction Procedure: neuromuscular transmission monitoring Procedure: Pulse oximetry measurement

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Study Type : Observational
Actual Enrollment : 625 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional / Observational Study on Postoperative Residual Curarisation at Arrival in the Post-anesthesia Care Unit After Spontaneous Recovery or After Reversal of the Neuromuscular Block
Study Start Date : May 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking


Intervention Details:
  • Procedure: neuromuscular transmission monitoring
    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.
  • Procedure: Pulse oximetry measurement
    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.


Primary Outcome Measures :
  1. incidence of postoperative residual curarisation [ Time Frame: 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. ]
    incidence of postoperative residual curarisation (PORC) defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit (PACU) arrival


Secondary Outcome Measures :
  1. Possible episodes of SpO2 <90% in the PACU [ Time Frame: During the first 30 min of PACU admission ]
  2. Airway maneuvers and/or stimulation required to maintain SpO2 >90% in the PACU [ Time Frame: During the first 30 min of PACU admission ]
    the requirement for either tactile or verbal stimulation to maintain SpO2 greater than 90%, and any clinical evidence of airway obstruction

  3. Need for re-intubation [ Time Frame: During the first 30 min of PACU admission ]


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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
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT01362647


Locations
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Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Guy Cammu, MD, PhD OLV Hospital, Aalst, Belgium
Publications:
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Responsible Party: Guy Cammu, MD, PhD, OLV Hospital, Aalst, Belgium
ClinicalTrials.gov Identifier: NCT01362647    
Other Study ID Numbers: B126201110617
IISP ID 39443 ( Other Grant/Funding Number: MSD (Merck Sharp & Dohme) )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011
Keywords provided by Onze Lieve Vrouw Hospital:
Muscle Relaxation
Additional relevant MeSH terms:
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Airway Obstruction
Hypoxia
Delayed Emergence from Anesthesia
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Postoperative Complications
Pathologic Processes