Postoperative Residual Curarisation at Arrival in the Post-anesthesia Care Unit
|ClinicalTrials.gov Identifier: NCT01362647|
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : October 5, 2011
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|
|Study Type :||Observational|
|Actual Enrollment :||625 participants|
|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|
- 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.
- 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
- Possible episodes of SpO2 <90% in the PACU [ Time Frame: During the first 30 min of PACU admission ]
- 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
- Need for re-intubation [ Time Frame: During the first 30 min of PACU admission ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362647
|Aalst, Belgium, 9300|
|Principal Investigator:||Guy Cammu, MD, PhD||OLV Hospital, Aalst, Belgium|