Pilot Study on the Pharmacodynamics of Sugammadex in Morbidly Obese Patients: Reversal of Deep Neuromuscular Blockade

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 comparing 1 mg/kg IBW versus 1 mg/kg TBW versus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Antonius Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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