<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01718236</url>
  </required_header>
  <id_info>
    <org_study_id>IGA NT 13906-4</org_study_id>
    <nct_id>NCT01718236</nct_id>
  </id_info>
  <brief_title>Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section</brief_title>
  <acronym>RocSugIO</acronym>
  <official_title>Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Anne's University Hospital Brno, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Olomouc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IGA - internal grant agency, Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brno University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project aims to introduce into clinical practice for Caesarean section conducted under&#xD;
      general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal of&#xD;
      neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same&#xD;
      efficiency and confirm the safety of the procedure for both mother and newborn compared with&#xD;
      older procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project &quot;Modern myorelaxation procedure and reversal of neuromuscular blockade during general&#xD;
      anesthesia for caesarean section&quot; aims to introduce in other indications for rapid induction&#xD;
      of general anesthesia common and safe, alternative method of combining short-acting&#xD;
      intravenous anesthetics propofol and fast-onset non-depolarizing muscle relaxant rocuronium&#xD;
      into the clinical practice and demonstrate the efficacy and safety in this indication. At the&#xD;
      same time to demonstrate the benefits of using modern reversal of neuromuscular blockade by&#xD;
      sugammadex in termination the caesarean section under general anesthesia. Both procedures&#xD;
      will be monitored by clinical observation, monitoring instrumentation and laboratory&#xD;
      examination of mother and fetus (newborn) in various stages of peripartal period. The main&#xD;
      benefit of this procedure will be in particular risk groups of mothers which are indicated by&#xD;
      Caesarean Section while neuraxial blockade is contraindicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time needed to tracheal intubation</measure>
    <time_frame>2 years</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total procedure time</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>complications during anesthesia and during perioperation period</measure>
    <time_frame>2 years</time_frame>
    <description>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</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Caesarean Section</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Rocuronium + sugammadex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubation after rocuronium administration and reversal of blockade after administration of sugammadex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Succinylcholine + Neostigmine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium + sugammadex</intervention_name>
    <description>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.</description>
    <arm_group_label>Rocuronium + sugammadex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Succinylcholine + Neostigmine</intervention_name>
    <description>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.</description>
    <arm_group_label>Succinylcholine + Neostigmine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caesarian section under general anesthesia in informed patient (after interview with&#xD;
             anesthesiologist and obtain the signature for informed consent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient disagreement&#xD;
&#xD;
          -  indicated and performed neuraxial blockade&#xD;
&#xD;
          -  the anesthesiologist or obstetrician opposition to their inclusion in the study&#xD;
&#xD;
          -  allergy or intolerance to one or more of study drug or known allergies or reactions to&#xD;
             iodine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petr Štourač, MD</last_name>
    <role>Study Director</role>
    <affiliation>Brno Faculty hospital, department of anesthesiology and intensive care medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty hospital Brno</name>
      <address>
        <city>Brno</city>
        <state>Jihomoravský Kraj</state>
        <zip>62500</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <state>Olomoucký kraj</state>
        <zip>775 20</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <link>
    <url>http://journals.lww.com/anesthesia-analgesia/Abstract/2016/05000/Low_Dose_or_High_Dose_Rocuronium_Reversed_with.43.aspx</url>
    <description>Published results of the study, full text available by principal investigator Stourac Petr.MD.Ph.D Doc.</description>
  </link>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>July 22, 2016</last_update_submitted>
  <last_update_submitted_qc>July 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>caesarean section</keyword>
  <keyword>rocuronium</keyword>
  <keyword>sugammadex</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
    <mesh_term>Succinylcholine</mesh_term>
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01718236
org study id: IGA NT 13906-4
nct id: NCT01718236
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: time needed to tracheal intubation
time frame: 2 years
description: 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)
measure: total procedure time
time frame: 2 years
description: 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.
measure: complications during anesthesia and during perioperation period
time frame: 2 years
description: 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
arm group label: Rocuronium + sugammadex
arm group type: Experimental
description: Intubation after rocuronium administration and reversal of blockade after administration of sugammadex
arm group label: Succinylcholine + Neostigmine
arm group type: Experimental
description: Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration
intervention type: Drug
intervention name: Rocuronium + sugammadex
description: 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.
arm group label: Rocuronium + sugammadex
intervention type: Drug
intervention name: Succinylcholine + Neostigmine
description: 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.
arm group label: Succinylcholine + Neostigmine
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 60 Years
healthy volunteers: No
last name: Petr Štourač, MD
role: Study Director
affiliation: Brno Faculty hospital, department of anesthesiology and intensive care medicine
facility: 
facility: 
country: Czech Republic
url: http://journals.lww.com/anesthesia-analgesia/Abstract/2016/05000/Low_Dose_or_High_Dose_Rocuronium_Reversed_with.43.aspx
description: Published results of the study, full text available by principal investigator Stourac Petr.MD.Ph.D Doc.
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: MD
mesh term: Rocuronium
mesh term: Succinylcholine
mesh term: Neostigmine