Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
RocSugIO
1 other identifier
interventional
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 26, 2016
July 1, 2016
2.3 years
October 24, 2012
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time needed to tracheal intubation
Quality: Rapid induction to general anesthesia with administration propofol and rocuronium for termination the pregnancy by Caesarean section are at least as good as the combination of propofol and succinylcholine iodide.Recording and evaluated will be the time from the beginning as the first drug in the rapid induction to general anesthesia will be administered until the discovery of the first wave of etCO2 after successful intubation (seconds), evaluation of intubation conditions (resistance to laryngoscopy, position of the vocal cords, response to the intubation attempt (limbs movement or cough) scored 1-3 according to level terms, conditions, entry scores for direct visualization of the vocal cords by Cormack-Lehane (I-IV)
2 years
Secondary Outcomes (1)
total procedure time
2 years
Other Outcomes (1)
complications during anesthesia and during perioperation period
2 years
Study Arms (2)
Rocuronium + sugammadex
EXPERIMENTALIntubation after rocuronium administration and reversal of blockade after administration of sugammadex
Succinylcholine + Neostigmine
EXPERIMENTALIntubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- caesarian section under general anesthesia in informed patient (after interview with anesthesiologist and obtain the signature for informed consent)
You may not qualify if:
- patient disagreement
- indicated and performed neuraxial blockade
- allergy or intolerance to one or more of study drug or known allergies or reactions to iodine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brno University Hospitallead
- St. Anne's University Hospital Brno, Czech Republiccollaborator
- University Hospital Olomouccollaborator
- IGA - internal grant agency, Ministry of Healthcollaborator
Study Sites (2)
Faculty Hospital Olomouc
Olomouc, Olomoucký kraj, 775 20, Czechia
Faculty hospital Brno
Brno, South Moravian, 62500, Czechia
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petr Štourač, MD
Brno Faculty hospital, department of anesthesiology and intensive care medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 31, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 26, 2016
Record last verified: 2016-07