Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine
Condition: Cesarean Section
MeSH terms: Disease
Intervention: Rocuronium; Succinylcholine
Intervention description: 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.; 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.
Intervention MeSH terms: Rocuronium; Succinylcholine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 91.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cesarean section; General anesthesia; neuromuscular blockade; Surgical conditions

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. 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  urgent Cesarean section

          -  multiple pregnancy

          -  abnormal placentation

          -  prematurity (<34 weeks)

          -  severe fetal hypoxia

          -  history of severe pre-existing disease

          -  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