Clinical trial NCT01718236: Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
Official title: Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarean Section
Pregnancy
Keywords: caesarean section
rocuronium
sugammadex
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: St. Anne's University Hospital Brno, Czech Republic
name: University Hospital Olomouc
name: IGA - internal grant agency, Ministry of Health
First posted: 2012-10-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: time needed to tracheal intubation
timeFrame: 2 years
Secondary outcomes:
measure: total procedure time
timeFrame: 2 years
Other outcomes:
measure: complications during anesthesia and during perioperation period
timeFrame: 2 years
Locations:
city: Brno
country: Czech Republic
facility: Faculty hospital Brno
state: Jihomoravský Kraj
city: Olomouc
country: Czech Republic
facility: Faculty Hospital Olomouc
state: Olomoucký kraj
Study officials:
affiliation: Brno Faculty hospital, department of anesthesiology and intensive care medicine
name: Petr Štourač, MD
role: STUDY_DIRECTOR
References: