Safety of Intraoperative Use of Muscle Relaxants and Their Reversal Agent Neostigmine
This trial is active, not recruiting.
|Conditions||postoperative residual curarization, impaired gas exchange, atelectasis, hospital length of stay, postoperative icu admission|
|Sponsor||Massachusetts General Hospital|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||April 2011|
|End date||February 2014|
|Trial size||3000 participants|
|Trial identifier||NCT01718860, 2011P000454, IISP#39443|
The investigators evaluate the assumption that postoperative residual curarization is associated with impaired gas exchange upon post anesthesia care unit arrival and longer hospital length of stay. Additionally, the investigators also evaluate the assumption the use of neostigmine reversal of residual neuromuscular block is associated with an increased incidence of postoperative pulmonary complications and intensive care unit admission.
The investigators enroll patients arriving in the postanesthesia care unit after receiving non-depolarizing neuromuscular blocking agents as part of their surgical anesthesia.
Impaired gas exchange
time frame: Within 10 min. upon PACU arrival
Hospital Length of Stay
time frame: within 100 days after surgery
Male or female participants at least 18 years old.
- Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia.
- Each subject must be at least 18 years of age
- The subject is scheduled to be transferred to an intensive care unit after surgery.
|Official title||Consequences on Respiratory Morbidity and Health-care Utilization of Partial Paralysis Upon Admission to the Postanesthesia Care.|
|Principal investigator||Matthias Eikermann, MD, PhD|
|Description||The investigators' laboratory has recently identified the intraoperative use of intermediate-acting non-depolarizing neuromuscular blocking agents and neostigmine reversal of neuromuscular blockade as independent risk factors for severe postoperative respiratory complications. Additionally, the investigators found that postoperative residual curarization (PORC), defined as a train-of-four ratio less than 0.90 upon postanesthesia care unit (PACU) arrival, is associated with an increased PACU length of stay. To examine the mechanisms contributing to the association of neuromuscular transmission failure with postoperative respiratory complications, the investigators aim to evaluate in a performance improvement driven initiative to better understand the association between the use of neuromuscular blocking agents and reversal agents with postoperative respiratory complications (see British Medical Journal 2012 Oct 15;345:e6329) if patients presenting with PORC develop subsequently 1) an increased incidence of postoperative impaired gas exchange upon PACU admission and result in 2) an increased hospital length of stay. In addition the investigators evaluated the effects of neostigmine on signs and symptoms of postoperative respiratory dysfunction and an incidence of unplanned postoperative intensive care unit admission.|
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