Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section (RocSugIO)

Brno University Hospital

Status and phase: Completed; Phase 4

Conditions: Caesarean Section; Pregnancy

Treatments: Drug: Rocuronium + sugammadex; Drug: Succinylcholine + Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT01718236

IGA NT 13906-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Rocuronium + sugammadex

Experimental group

Description:

Intubation after rocuronium administration and reversal of blockade after administration of sugammadex

Treatment:

Drug: Rocuronium + sugammadex

Succinylcholine + Neostigmine

Experimental group

Description:

Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration

Treatment:

Drug: Succinylcholine + Neostigmine