Cesarean SectionPhase 4NCT01941628
Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine
A Phase 4 study testing Rocuronium and Succinylcholine in people with Cesarean Section, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Rocuronium and Succinylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Aug 2014to 3 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women undergoing Cesarean section under general anesthesia
- at least 18 years of age
- results of a physical and laboratory preoperative examination within normal limits or clinically acceptable limits for the study
- written informed consent
Who cannot join
- urgent Cesarean section
- multiple pregnancy
- abnormal placentation
- prematurity (<34 weeks)
- severe fetal hypoxia
- history of severe pre-existing disease
Show all 12Show fewer
- hypersensitivity or allergy to rocuronium or sugammadex
- Discontinuation Criteria:
- a subject's choice to end participation in the study
- a subject meets any exclusion criteria during the study or equivalent criteria
- lost to follow up
- the investigator feels that it's in the subject's best interest to discontinue the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel Design Study to Compare Surgical Conditions for Fetus Delivery and Suture of the Uterus and Abdominal Wall in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine
Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. The shortest possible interval is essential for the amount of anesthetics crossing placenta into the fetal circulation.
The primary objective:
Read more
To compare surgical conditions for fetus delivery in Cesarean section under general anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine.
The primary safety objective:
To compare influence of different levels of neuromuscular blockade and surgical conditions on newborn adaptation after the Cesarean delivery.
The secondary objectives:
To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean section on surgical conditions for suture of the uterus and the abdominal wall with attention to blood loss, time of surgery and surgical complications.
To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of procedure.
Clinical hypotheses:
The use of deep muscle blockade in Cesarean section under general anesthesia, including the period of fetus delivery, compare to the standard recommended practice with succinylcholine, will improve the surgical conditions and allow faster and easier delivery of the fetus with positive effect on its postnatal adaptation. Faster delivery will reduce an incision to delivery interval with decrease of time between anesthetics administration and delivery. This will reduce the amount of anesthetics crossing the placenta to the fetal circulation. Both, reduced amount of anesthetics and reduced incision to delivery interval itself will improve a newborn adaptation after Cesarean delivery.
Deep neuromuscular blockade will also improve surgical conditions for the whole surgery, when no or shallow only neuromuscular blockade is routinely used. We assume that deep neuromuscular blockade during the entire surgery will create better surgical conditions for faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood loss and incidence of surgical complications.
Read the detailed description
Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. The shortest possible interval is essential for the amount of anesthetics crossing placenta into the fetal circulation.
The same requirement for the fastest time applies for the suture of uterus, when the duration of suture directly affects an amount of blood loss. Hence creating the best surgical conditions allowing the fastest delivery and performance of whole surgery, safe for the fetus and the mother, should be an extremely important. The question is, whether recent recommendations for Cesarean section under general anesthesia best meet these requirements. We assume that by creating better surgical conditions it could be positively affected not only the time and safety of fetus delivery (and thus its adaptation), but also the reduction of perioperative blood loss and the incidence of surgical complications (primarily subfascial hematoma, bladder injury, dehiscence, surgical site infection).
For higher risk of regurgitation and aspiration rapid sequence induction into the general anesthesia is the method of choice for Cesarean section for more than last forty years [1]. This means that intubation in apnoeic pause should be performed as soon as possible after administration of anesthetics and muscle relaxant. The traditional basic requirements on the administered muscle relaxant then primarily are a time of onset of its action and a creation of good intubating conditions. The depolarizing agent succinylcholine (1 to 1.5 mg/kg) is still worldwide recommended the muscle relaxant of choice for most parturients undergoing rapid-sequence induction for general anesthesia as provides adequate intubating conditions within approximately 45 seconds of intravenous administration [2]. But essential likewise is, that administration of muscle relaxant does not affect only the creation of intubating conditions, but the effect on relaxation of the abdominal wall muscles has an effect also on surgical conditions for fetus delivery. Surprisingly, and to our knowledge, this effect has not been studied yet. From this perspective, and taking into account the negative effects of succinylcholine, rocuronium seems to be preferable alternative. Rocuronium in the dose of 0.6 mg/kg in pregnant women induces good intubating conditions similar to succinylcholine [1, 3, 4], in a still reasonable time for apnoeic intubation [5]. But compare to succinylcholine, which allows only very short muscle blockade (and may thus prolong a delivery in complicated cases with all the consequences on postnatal fetus adaptation), rocuronium induces deep muscle relaxation and so should offer better surgical conditions for easier and faster fetus delivery.
As stated in recent recommendations, additional neuromuscular blockade after fetus delivery is either not necessary (provided that the mother has an adequate depth of anesthesia with administration of both a volatile agent and an opioid), or a small dose of a short-acting nondepolarizing agent (or an infusion of succinylcholine) can be administered [2]. This means, if succinylcholine is used as a muscle relaxant, due to its very short action the surgery is performed in no or shallow only neuromuscular blockade. We again assume that deep neuromuscular blockade during the surgery will offer better surgical conditions for suture of the uterus and the rest of surgery and thus reduce time of the surgery and perioperative blood loss and even incidence of surgical complications. Such comparison has not been studied to date.
Comparison of surgical conditions for fetus delivery and its influence on fetus adaptation has not been also investigated yet. Unanswered question then is, whether deep muscle blockade wit rocuronium, allowing improved surgical conditions can also improve newborn adaptation compare to traditional approach with succinylcholine.
- Conditions
- Cesarean Section
- Being tested
- Rocuronium, Succinylcholine
- Keywords
- Cesarean section, General anesthesia, neuromuscular blockade, Surgical conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Rocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis.
SuccinylcholineDrug
Standard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Experimental | In this group rocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis. Receives: Drug: Rocuronium |
| Succinylcholine | Active comparator | Standard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered. Receives: Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to Delivery Interval
Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.
Measured: 24 hrs
Number of Participants With Newborn in Need of Respiratory Support
The number of participants with a newborn in need of respiratory support will be the primary safety measure in comparison of the influence of different neuromuscular blockade levels on newborn adaptation.
Measured: 24 hours
Secondary outcomes (1)
Peroperative and Postoperative Surgical Complication
A total number of surgical complications evaluated at day 5 after Caesarean delivery.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start16 Aug 2014
- Primary completion30 Dec 2016
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Principal investigator, Jan Blaha, MD, PhD., Charles University, Czech Republic
- Investigators
- Jan Blaha, MD, PhD, Principal investigator, Charles University, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941628
- Sponsor's protocol ID
- RocSuc
- Other IDs
- 2013-003077-97
- Status last verified
- Feb 2019
- First submitted
- 5 Sep 2013
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel Design Study to Compare Surgical Conditions for Fetus Delivery and Suture of the Uterus and Abdominal Wall in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine
- ClinicalTrials.gov ID
- NCT01941628
- Acronym / sponsor ID
- RocSuc
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, General anesthesia, neuromuscular blockade, Surgical conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 16 Aug 2014 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. The shortest possible interval is essential for the amount of anesthetics crossing placenta into the fetal circulation.
The primary objective:
To compare surgical conditions for fetus delivery in Cesarean section under general anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine.
The primary safety objective:
To compare influence of different levels of neuromuscular blockade and surgical conditions on newborn adaptation after the Cesarean delivery.
The secondary objectives:
To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean section on surgical conditions for suture of the uterus and the abdominal wall with attention to blood loss, time of surgery and surgical complications.
To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of procedure.
Clinical hypotheses:
The use of deep muscle blockade in Cesarean section under general anesthesia, including the period of fetus delivery, compare to the standard recommended practice with succinylcholine, will improve the surgical conditions and allow faster and easier delivery of the fetus with positive effect on its postnatal adaptation. Faster delivery will reduce an incision to delivery interval with decrease of time between anesthetics administration and delivery. This will reduce the amount of anesthetics crossing the placenta to the fetal circulation. Both, reduced amount of anesthetics and reduced incision to delivery interval itself will improve a newborn adaptation after Cesarean delivery.
Deep neuromuscular blockade will also improve surgical conditions for the whole surgery, when no or shallow only neuromuscular blockade is routinely used. We assume that deep neuromuscular blockade during the entire surgery will create better surgical conditions for faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood loss and incidence of surgical complications.
Detailed description
Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. The shortest possible interval is essential for the amount of anesthetics crossing placenta into the fetal circulation.
The same requirement for the fastest time applies for the suture of uterus, when the duration of suture directly affects an amount of blood loss. Hence creating the best surgical conditions allowing the fastest delivery and performance of whole surgery, safe for the fetus and the mother, should be an extremely important. The question is, whether recent recommendations for Cesarean section under general anesthesia best meet these requirements. We assume that by creating better surgical conditions it could be positively affected not only the time and safety of fetus delivery (and thus its adaptation), but also the reduction of perioperative blood loss and the incidence of surgical complications (primarily subfascial hematoma, bladder injury, dehiscence, surgical site infection).
For higher risk of regurgitation and aspiration rapid sequence induction into the general anesthesia is the method of choice for Cesarean section for more than last forty years [1]. This means that intubation in apnoeic pause should be performed as soon as possible after administration of anesthetics and muscle relaxant. The traditional basic requirements on the administered muscle relaxant then primarily are a time of onset of its action and a creation of good intubating conditions. The depolarizing agent succinylcholine (1 to 1.5 mg/kg) is still worldwide recommended the muscle relaxant of choice for most parturients undergoing rapid-sequence induction for general anesthesia as provides adequate intubating conditions within approximately 45 seconds of intravenous administration [2]. But essential likewise is, that administration of muscle relaxant does not affect only the creation of intubating conditions, but the effect on relaxation of the abdominal wall muscles has an effect also on surgical conditions for fetus delivery. Surprisingly, and to our knowledge, this effect has not been studied yet. From this perspective, and taking into account the negative effects of succinylcholine, rocuronium seems to be preferable alternative. Rocuronium in the dose of 0.6 mg/kg in pregnant women induces good intubating conditions similar to succinylcholine [1, 3, 4], in a still reasonable time for apnoeic intubation [5]. But compare to succinylcholine, which allows only very short muscle blockade (and may thus prolong a delivery in complicated cases with all the consequences on postnatal fetus adaptation), rocuronium induces deep muscle relaxation and so should offer better surgical conditions for easier and faster fetus delivery.
As stated in recent recommendations, additional neuromuscular blockade after fetus delivery is either not necessary (provided that the mother has an adequate depth of anesthesia with administration of both a volatile agent and an opioid), or a small dose of a short-acting nondepolarizing agent (or an infusion of succinylcholine) can be administered [2]. This means, if succinylcholine is used as a muscle relaxant, due to its very short action the surgery is performed in no or shallow only neuromuscular blockade. We again assume that deep neuromuscular blockade during the surgery will offer better surgical conditions for suture of the uterus and the rest of surgery and thus reduce time of the surgery and perioperative blood loss and even incidence of surgical complications. Such comparison has not been studied to date.
Comparison of surgical conditions for fetus delivery and its influence on fetus adaptation has not been also investigated yet. Unanswered question then is, whether deep muscle blockade wit rocuronium, allowing improved surgical conditions can also improve newborn adaptation compare to traditional approach with succinylcholine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Experimental | Drug: RocuroniumIn this group rocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis. |
| Succinylcholine | Active comparator | Drug: SuccinylcholineStandard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women undergoing Cesarean section under general anesthesia
- at least 18 years of age
- results of a physical and laboratory preoperative examination within normal limits or clinically acceptable limits for the study
- written informed consent
Key exclusion criteria (12 listed)
- urgent Cesarean section
- multiple pregnancy
- abnormal placentation
- prematurity (<34 weeks)
- severe fetal hypoxia
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 |
|---|---|---|
| RocuroniumRocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis. | Drug | Rocuronium |
| SuccinylcholineStandard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered. | Drug | Succinylcholine |
Primary outcome
Induction to Delivery Interval
Time frame: 24 hrs
Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.
Number of Participants With Newborn in Need of Respiratory Support
Time frame: 24 hours
The number of participants with a newborn in need of respiratory support will be the primary safety measure in comparison of the influence of different neuromuscular blockade levels on newborn adaptation.
1 secondary outcome
Peroperative and Postoperative Surgical Complication
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jan Blaha, MD, PhD principal investigator
Charles University, Prague
1 site 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 and Succinylcholine in people with Cesarean Section, run by Charles University, Czech Republic at 1 site 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 4 inclusion and 12 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Induction to Delivery Interval (time frame: 24 hrs). The study lists 2 primary outcomes in all. 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 11 Feb 2019.