No registrations found.
ID
Source
Brief title
Health condition
Sugammadex, Train of four ratio, Respiration, Post operative
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative SpO2 level obtained at 2-min interval for 45 minutes and the need for supplemental oxygen
Secondary outcome
Pain, respiratory rate, sedation and lowest TOF ratio
Background summary
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.
Study objective
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
Study design
- Peroperative: bispectral index, TOF count, TOF ratio
- Postoperative: SpO2, respiratory rate, oxygen consumption, pain, sedation, occurence of nausea/vomiting, blood pressure, heart rate
Intervention
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
M Boon
Leiden 2333 ZA
The Netherlands
+31 (0)71 5299891
m.boon@lumc.nl
M Boon
Leiden 2333 ZA
The Netherlands
+31 (0)71 5299891
m.boon@lumc.nl
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5262 |
| NTR-old | NTR5378 |
| Other | Medisch Ethische Toetsingscommissie (METC) : P14.060 |