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

NCT01718236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-07-26

No results posted yet for this study

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.

Conditions

  • Caesarean Section
  • Pregnancy

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • St. Anne's University Hospital Brno, Czech Republic

    collaborator OTHER

  • University Hospital Olomouc

    collaborator OTHER

  • IGA - internal grant agency, Ministry of Health

    collaborator UNKNOWN

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Petr Štourač, MD · Brno Faculty hospital, department of anesthesiology and intensive care medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718236 on ClinicalTrials.gov