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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


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.


Minimum age: 14 Years. Maximum age: 60 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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