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

NCT ID: NCT01718236

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Caesarean Section; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rocuronium + sugammadex

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

Group Type: EXPERIMENTAL

Rocuronium + sugammadex

Intervention Type: DRUG

Administration of rocuronium 1 mg/kg, intubation at decrease in Single Twitch to 10% of baseline event. by the disappearance of visible spikes event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, neuromuscular blockade TOF count at 1-2.At the end of operation at PTC 1-2 sugammadex 4 mg/kg, at the TOF count 1-2, sugammadex 2 mg/kg, in the case of failure to achieve these values the anesthesiologist will wait until the minimum value of PTC 1-2 will be achieved. In can not intubate can not ventilate, and the failure of the introduction of laryngeal masks sugammadex 16mg/kg, immediately following the discovery of this fact and wait for the recovery of muscle strength. Time to recovery is recorded.

Succinylcholine + Neostigmine

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

Group Type: EXPERIMENTAL

Succinylcholine + Neostigmine

Intervention Type: DRUG

1mg/kg succinylcholine iodide, intubation after decrease in Single Twitch to 10% of baseline event. after the disappearance of visible fasciculation event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, at the moment of 20-30% of the original value of Single Twitch rocuronium 0.3 mg / kg, maintaining TOF Count at 1-2.At the end of operation at TOF Count 1-2 atropine 0.01 mg/kg and neostigmine 0.03 mg/kg. If TOF not 1-2 wait.In can not intubate can not ventilate, wait for the spontaneous recovery. Time to recovery of muscle strength is recorded.

Interventions

Rocuronium + sugammadex

Administration of rocuronium 1 mg/kg, intubation at decrease in Single Twitch to 10% of baseline event. by the disappearance of visible spikes event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, neuromuscular blockade TOF count at 1-2.At the end of operation at PTC 1-2 sugammadex 4 mg/kg, at the TOF count 1-2, sugammadex 2 mg/kg, in the case of failure to achieve these values the anesthesiologist will wait until the minimum value of PTC 1-2 will be achieved. In can not intubate can not ventilate, and the failure of the introduction of laryngeal masks sugammadex 16mg/kg, immediately following the discovery of this fact and wait for the recovery of muscle strength. Time to recovery is recorded.

Intervention Type: DRUG

Succinylcholine + Neostigmine

1mg/kg succinylcholine iodide, intubation after decrease in Single Twitch to 10% of baseline event. after the disappearance of visible fasciculation event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, at the moment of 20-30% of the original value of Single Twitch rocuronium 0.3 mg / kg, maintaining TOF Count at 1-2.At the end of operation at TOF Count 1-2 atropine 0.01 mg/kg and neostigmine 0.03 mg/kg. If TOF not 1-2 wait.In can not intubate can not ventilate, wait for the spontaneous recovery. Time to recovery of muscle strength is recorded.

Intervention Type: DRUG

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

IGA - internal grant agency, Ministry of Health

UNKNOWN

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Štourač, MD

Role: STUDY_DIRECTOR

Brno Faculty hospital, department of anesthesiology and intensive care medicine

Locations

Faculty Hospital Olomouc

Olomouc, Olomoucký kraj, Czechia

Faculty hospital Brno

Brno, South Moravian, Czechia

Countries

Czechia

Related Links

http://journals.lww.com/anesthesia-analgesia/Abstract/2016/05000/Low_Dose_or_High_Dose_Rocuronium_Reversed_with.43.aspx

Published results of the study, full text available by principal investigator Stourac Petr.MD.Ph.D Doc.

Other Identifiers

IGA NT 13906-4

Identifier Type: -

Identifier Source: org_study_id