Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
Information source: Brno University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Caesarean Section; Pregnancy
Intervention: Rocuronium + sugammadex (Drug); Succinylcholine + Neostigmine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Brno University Hospital Official(s) and/or principal investigator(s):
Petr Štourač, MD, Study Director, Affiliation: Brno Faculty hospital, department of anesthesiology and intensive care medicine
Summary
The project aims to introduce into clinical practice for Caesarean section conducted under
general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal
of neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same
efficiency and confirm the safety of the procedure for both mother and newborn compared with
older procedure.
Clinical Details
Official title: Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: time needed to tracheal intubation
Secondary outcome: total procedure time
Detailed description:
Project "Modern myorelaxation procedure and reversal of neuromuscular blockade during
general anesthesia for caesarean section" aims to introduce in other indications for rapid
induction of general anesthesia common and safe, alternative method of combining
short-acting intravenous anesthetics propofol and fast-onset non-depolarizing muscle
relaxant rocuronium into the clinical practice and demonstrate the efficacy and safety in
this indication. At the same time to demonstrate the benefits of using modern reversal of
neuromuscular blockade by sugammadex in termination the caesarean section under general
anesthesia. Both procedures will be monitored by clinical observation, monitoring
instrumentation and laboratory examination of mother and fetus (newborn) in various stages
of peripartal period. The main benefit of this procedure will be in particular risk groups
of mothers which are indicated by Caesarean Section while neuraxial blockade is
contraindicated.
Eligibility
Minimum age: 14 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- caesarian section under general anesthesia in informed patient (after interview with
anesthesiologist and obtain the signature for informed consent)
Exclusion Criteria:
- patient disagreement
- indicated and performed neuraxial blockade
- the anesthesiologist or obstetrician opposition to their inclusion in the study
- allergy or intolerance to one or more of study drug or known allergies or reactions
to iodine
Locations and Contacts
Faculty hospital Brno, Brno, Jihomoravský Kraj 62500, Czech Republic
Faculty Hospital Olomouc, Olomouc, Olomoucký kraj 775 20, Czech Republic
Additional Information
Current information about the trial
Starting date: September 2012
Last updated: January 27, 2015
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