Status:
UNKNOWN
Pilot Study on the Pharmacodynamics of Sugammadex in Morbidly Obese Patients: Reversal of Deep Neuromuscular Blockade
Lead Sponsor:
St. Antonius Hospital
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? To study the pharmacodynamics of sugammadex in morbidly obese patients by compar...
Detailed Description
Background of the study: Morbidly obese patients selected for elective bariatric surgery have major anesthetic concerns. The risks include a difficult airway, difficult mask ventilation, hypoxemia, p...
Eligibility Criteria
Inclusion
- must have a Body Mass Index \> 40 kg/m2
- must be between 18-65 years old
- must have an American Society of Anesthesiologists (ASA) physical status II to III
Exclusion
- Must not have Renal insufficiency identified by GFR \< 60 ml/min/1.73m2
- Sevoflurane must not be used since this can enhance neuromuscular blockade
- No previous succinylcholine must be used in the last 24 hours
- No use of other medication that can enhance neuromuscular blockade such as aminoglycoside- and polypeptide-antibiotics, lincosamide, acylamino-penicillin-antibiotics, tetracycline, high dose of metronidazol, M.A.O.-inhibitors, kinidine, magnesium, calcium channel blockers, lithium.
- No use of other medication that can decrease the neuromuscular blockade such as neostigmine, edrofonium, pyridostigmine, aminopyridine derivates, chronic use of corticosteroids, phenytoïne or carbamazepine, noradrenaline, azathioprine, theophylline, calcium chloride, kaliumchloride.
- hypersensitivity (allergic) to sugammadex or any of the preservatives.
- an ejection fraction of less than 35%
- Liver failure
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01855217
Start Date
April 1 2013
End Date
April 1 2014
Last Update
May 17 2013
Active Locations (1)
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1
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM