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

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ClinicalTrials.gov Identifier: NCT01718236
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
St. Anne's University Hospital Brno, Czech Republic
University Hospital Olomouc
IGA - internal grant agency, Ministry of Health
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Tracking Information
First Submitted Date  ICMJE October 24, 2012
First Posted Date  ICMJE October 31, 2012
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
time needed to tracheal intubation [ Time Frame: 2 years ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01718236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
total procedure time [ Time Frame: 2 years ]
Economics: After reversal of neuromuscular blockade using sugammadex are procedure time and turnovers shorter than the use of neostigmine in the recommended dosage for patients undergoing termination of pregnancy by Caesarean section. Recording and evaluated will be the total procedure time until the recovery from neuromuscular blockade to the level of TOF ratio of 0.9, the administration of the recovery dose will in group ROCSUG in the case for posttetanic count mode in the level of PTC1, 2 at a dose of sugammadex 4mg/kg , the TOF count 1.2 sugammadex at a dose of 2 mg / kg, in the case of failure to achieve these values the anesthesiologist wil wait with the administration of the recovery dose for their achievement. In group SUCNEO for achieving TOF count 1.2 and higher, the dose of atropine to 0.01 mg / kg and neostigmine 0.03 mg / kg will be administered.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2012)
complications during anesthesia and during perioperation period [ Time Frame: 2 years ]
Rocuronium, sugammadex doesn´t lead to the deterioration of perinatal parameters and leads to fewer complications during anesthesia and postoperative period against a combination of succinylcholine iodide, rocuronium and neostigmine.Demographic characteristics (age,weight,BMI,gain in pregnancy,previous pregnancy, complications during pregnancy,medication during pregnancy), multiple gestation,parity,fetal position,the reason for the indication of caesarean section, the reason for general anesthesia caesarean section,week of termination of pregnancy,fetal weight,umbilical cord blood pH, pCO2,pO2,BE,Apgar,sex of the fetus,STAN or CTG assessment,the nature of amniotic fluid,time to cutting the umbilical cord will be monitored. Anesthesia complications (present or absent),the evaluation questionnaire of subjective feelings of the patient 1 day after caesarean section - sore throat,vigilance during anesthesia,myalgia,diplopia,weakness,inability to cough,shortness of breath will be recorded
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
Official Title  ICMJE Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Caesarean Section
  • Pregnancy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Rocuronium + sugammadex
    Intubation after rocuronium administration and reversal of blockade after administration of sugammadex
    Intervention: Drug: Rocuronium + sugammadex
  • Experimental: Succinylcholine + Neostigmine
    Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration
    Intervention: Drug: Succinylcholine + Neostigmine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2015)
500
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2012)
240
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01718236
Other Study ID Numbers  ICMJE IGA NT 13906-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Petr Štourač, MD, Brno University Hospital
Study Sponsor  ICMJE Brno University Hospital
Collaborators  ICMJE
  • St. Anne's University Hospital Brno, Czech Republic
  • University Hospital Olomouc
  • IGA - internal grant agency, Ministry of Health
Investigators  ICMJE
Study Director: Petr Štourač, MD Brno Faculty hospital, department of anesthesiology and intensive care medicine
PRS Account Brno University Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP