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Effect of neuromuscular blockade reversal with sugammadex on oxygenation, pain and arousal states in the post-anesthesia care unit


- candidate number22699
- NTR NumberNTR5378
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2015
- Secondary IDsP14.060 Medisch Ethische Toetsingscommissie (METC)
- Public TitleEffect of neuromuscular blockade reversal with sugammadex on oxygenation, pain and arousal states in the post-anesthesia care unit
- Scientific TitleEffect of neuromuscular blockade reversal with sugammadex on oxygenation, pain and arousal states in the post-anesthesia care unit
- ACRONYMNeuropa
- hypothesisWe hypothesize that reversal with sugammadex leads to favorable postoperative respiratory conditions, less sedation and lower pain levels as compared to reversal with the (traditionally used) acetylcholinesterase inhibitor neostigmin
- Healt Condition(s) or Problem(s) studiedSugammadex, Post operative, Respiratory complications
- Inclusion criteria- Age >18 years
- Body mass index < 35 kg/m2
- ASA class I-III
- Patients scheduled for elective surgery requiring anesthesia with the use of neuromuscular blocking agents.
- Exclusion criteria- Known or suspected neuromuscular disorder impairing neuromuscular function
- Allergie to muscle relaxants, anesthesics or narcotics.
- A (family) history of malignant hyperthermia
- Women who are or may be pregnant or are currently breast feeding
- Contraindication for the use of neostigmine (intestinal obstruction, COPD GOLD 4 or abnormal heart rhythm)
- Surgery requiring neuraxial anesthesia/analgesia
- Preoperative cognitive dysfunction or mental disabilities
- Preexistent significant pulmonary disease with preoperative SpO2<90%
- Preoperative ICU treatment/intubation (ICU patient);
- Need for postoperative ICU treatment or ventilation
- Renal insufficiency (GFR<30 mL/min or oligura < 0.5 mg/kg/h)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate31-dec-2016
- Target number of participants100
- InterventionsAccording to the randomization list the patient will receive at the end of the surgery sugammadex 2mg/kg or neostigmine 2.5 mg + atropine 1 mg at a NMB level of TOF>0
- Primary outcomePostoperative SpO2 level obtained at 2-min interval for 45 minutes and the need for supplemental oxygen
- Secondary outcomePain, respiratory rate, sedation and lowest TOF ratio
- Timepoints- Peroperative: bispectral index, TOF count, TOF ratio
- Postoperative: SpO2, respiratory rate, oxygen consumption, pain, sedation, occurence of nausea/vomiting, blood pressure, heart rate
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M Boon
- CONTACT for SCIENTIFIC QUERIES M Boon
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
MSD
- Publications
- Brief summaryMuscle relaxants are routinely used during general anesthesia. However, when at the end of surgery reversal is suboptimal, it's use is assiociated with an increase in postoperative complication, most importantly hypoxemia in the first 30-45minutes in the recovery room. Since 2008 an intense and rapid reversal of a rocuronium-induced neuromuscular block is possible with the use of sugammadex.
The current study is aimed at assessing the effect of sugammadex on the postoperative respiratory condition compared to the (traditionnally used) neostigmin. The patient will be randomized to receive sugammadex or neostigmin as reversal of the neuromuscular block and respiratory conditions will be monitored during the first 45minutes at the recovery room.
- Main changes (audit trail)
- RECORD11-aug-2015 - 6-okt-2015


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