Pilot Study on the Pharmacodynamics of Sugammadex in Morbidly Obese Patients: Reversal of Deep Neuromuscular Blockade
MOS
1 other identifier
interventional
25
1 country
1
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 comparing 1 mg/kg IBW versus 1 mg/kg TBW versus placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 17, 2013
May 1, 2013
1 year
April 2, 2013
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
50% TOF-recovery after sugammadex
• Time to Train-of-four 50%
0-30 minutes
Secondary Outcomes (1)
Time to TOF 5% and 25%
0-30 minutes
Other Outcomes (2)
Relation between TOF% and covariates (TBW, IBW, age, gender etc)
0-30 minutes
Quality of surgical conditions from muscle relaxation point of view.
0-end of surgery ( approx 60-90 min)
Study Arms (3)
Sugammadex total body weight
ACTIVE COMPARATOR1 mg/kg total body weight
Sugammadex ideal body weight
ACTIVE COMPARATOR1 mg /kg ideal body weight
placebo
PLACEBO COMPARATORplacebo 0,9% NaCl
Interventions
1 mg/kg total BW based sugammadex reversal of deep block
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sint Antonius Ziekenhuis
Nieuwegein, 3430 EM, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
H PA van Dongen
St. Antonius Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 2, 2013
First Posted
May 16, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 17, 2013
Record last verified: 2013-05