Caesarean SectionPhase 4RocSugIONCT01718236
Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
A Phase 4 study testing Rocuronium + sugammadex and Succinylcholine + Neostigmine in people with Caesarean Section and Pregnancy, run by Brno University Hospital at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Caesarean Section, Pregnancy
- What is being tested?
- Rocuronium + sugammadex and Succinylcholine + Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesCzechia
- Study dates
- Sep 2012to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- caesarian section under general anesthesia in informed patient (after interview with anesthesiologist and obtain the signature for informed consent)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Faculty hospital Brno
Brno, South Moravian, 62500
Faculty Hospital Olomouc
Olomouc, Olomouc Region, 775 20
About this study
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.
Read the 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.
- Conditions
- Caesarean Section, Pregnancy
- Being tested
- Rocuronium + sugammadex, Succinylcholine + Neostigmine
- Keywords
- caesarean section, rocuronium, sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium + sugammadexDrug
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.
Succinylcholine + NeostigmineDrug
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 group | Role | What they receive |
|---|---|---|
| Rocuronium + sugammadex | Experimental | Intubation after rocuronium administration and reversal of blockade after administration of sugammadex Receives: Drug: Rocuronium + sugammadex |
| Succinylcholine + Neostigmine | Experimental | Intubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration Receives: Drug: Succinylcholine + Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (1)
total procedure time
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, University Hospital Olomouc, IGA - internal grant agency, Ministry of Health
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, MD, Study director, Brno Faculty hospital, department of anesthesiology and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718236
- Sponsor's protocol ID
- IGA NT 13906-4
- Acronym
- RocSugIO
- Status last verified
- Jul 2016
- First submitted
- 24 Oct 2012
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section
- ClinicalTrials.gov ID
- NCT01718236
- Acronym / sponsor ID
- RocSugIO / IGA NT 13906-4
- Conditions
- Caesarean Section, Pregnancy
- Keywords
- caesarean section, rocuronium, sugammadex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, University Hospital Olomouc, IGA - internal grant agency, Ministry of Health
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium + sugammadex | Experimental | Drug: Rocuronium + sugammadexIntubation after rocuronium administration and reversal of blockade after administration of sugammadex |
| Succinylcholine + Neostigmine | Experimental | Drug: Succinylcholine + NeostigmineIntubation after succinylcholine administration, neuromuscular block is than maintained by rocuronium administration and reversal of block is by neostigmine + atropine administration |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- caesarian section under general anesthesia in informed patient (after interview with anesthesiologist and obtain the signature for informed consent)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium + sugammadexAdministration 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 | Rocuronium + sugammadex |
| Succinylcholine + Neostigmine1mg/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. | Drug | Succinylcholine + Neostigmine |
Primary outcome
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)
1 secondary outcome
total procedure time
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Published results of the study, full text available by principal investigator Stourac Petr.MD.Ph.D Doc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, MD study director
Brno Faculty hospital, department of anesthesiology and intensive care medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium + sugammadex and Succinylcholine + Neostigmine in people with Caesarean Section and Pregnancy, run by Brno University Hospital at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time needed to tracheal intubation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.