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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brno University Hospital
Sponsor:
Collaborators:
Faculty hospital Brno, Czech Republic, EU
Faculty hospital Olomouc, Czech Republic, EU
IGA - internal grant agency, Ministry of Health
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital
ClinicalTrials.gov Identifier:
NCT01718236
First received: October 24, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Caesarean Section
Pregnancy
Drug: Rocuronium + sugammadex
Drug: Succinylcholine + Neostigmine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section

Resource links provided by NLM:


Further study details as provided by Brno University Hospital:

Primary Outcome Measures:
  • time needed to tracheal intubation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • total procedure time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • complications during anesthesia and during perioperation period [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rocuronium + sugammadex
Intubation after rocuronium administration and reversal of blockade after administration of sugammadex
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.
Experimental: Succinylcholine + Neostigmine
Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718236

Contacts
Contact: Petr Štourač, MD +420 602 745 841 petr.stourac@gmail.com
Contact: Jozef Klučka, MD +420776187053 jozefklucka@seznam.cz

Locations
Czech Republic
Faculty hospital Brno Recruiting
Brno, Jihomoravský Kraj, Czech Republic, 62500
Contact: Petr Štourač, MD    +420 602 745 841    petr.stourac@gmail.com   
Sub-Investigator: Jozef Klučka, MD         
Sub-Investigator: Roman Štoudek, MD         
Sub-Investigator: Ivo Křikava, MD         
Sub-Investigator: Petr Janků, MD, Ph.D         
Sub-Investigator: Ivana Bártíková, MD         
Sub-Investigator: Zuzana Hodická, MD, Ph.D         
Sub-Investigator: Pavel Ševčík, Prof.MD.CSc.         
Sub-Investigator: Dagmar Seidlová, MD, Ph.D         
Principal Investigator: Petr Štourač, MD         
Faculty Hospital Olomouc Recruiting
Olomouc, Olomoucký kraj, Czech Republic, 775 20
Contact: Milan Adamus, Doc.MD.CSc.       Milan.Adamus@akutne.cz   
Sub-Investigator: Martina Kirchnerová, MD         
Sub-Investigator: Jana Frančáková, MD         
Sub-Investigator: Lenka Obare Pyszková, MD         
Sub-Investigator: Zdeněk Mrozek, MD, Ph.D         
Sub-Investigator: Jarmila Hložková, MD         
Principal Investigator: Milan Adamus, Doc.MD.CSc.         
Sponsors and Collaborators
Brno University Hospital
Faculty hospital Brno, Czech Republic, EU
Faculty hospital Olomouc, Czech Republic, EU
IGA - internal grant agency, Ministry of Health
Investigators
Study Director: Petr Štourač, MD Brno Faculty hospital, department of anesthesiology and intensive care medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Petr Štourač, MD, MD, Brno University Hospital
ClinicalTrials.gov Identifier: NCT01718236     History of Changes
Other Study ID Numbers: IGA NT 13906-4
Study First Received: October 24, 2012
Last Updated: July 15, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Brno University Hospital:
caesarean section
rocuronium
sugammadex

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Succinylcholine
Neostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on October 16, 2014