We 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
ID
Bron
Verkorte titel
Aandoening
Sugammadex, Train of four ratio, Respiration, Post operative
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Postoperative SpO2 level obtained at 2-min interval for 45 minutes and the need for supplemental oxygen
Achtergrond van het onderzoek
Muscle 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.
Doel van het onderzoek
We 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
Onderzoeksopzet
- Peroperative: bispectral index, TOF count, TOF ratio
- Postoperative: SpO2, respiratory rate, oxygen consumption, pain, sedation, occurence of nausea/vomiting, blood pressure, heart rate
Onderzoeksproduct en/of interventie
According 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
Publiek
M Boon
Leiden 2333 ZA
The Netherlands
+31 (0)71 5299891
m.boon@lumc.nl
Wetenschappelijk
M Boon
Leiden 2333 ZA
The Netherlands
+31 (0)71 5299891
m.boon@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
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| Register | ID |
|---|---|
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| NTR-old | NTR5378 |
| Ander register | Medisch Ethische Toetsingscommissie (METC) : P14.060 |