Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine

• Status: Completed
• Trial end date: 2018-04-03
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles University, Czech Republic
• Collaborator: General University Hospital, Prague
• Treatments: Anesthetics; Rocuronium; Succinylcholine

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