Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine
Information source: Charles University, Czech Republic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cesarean Section
Intervention: Rocuronium (Drug); Succinylcholine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Charles University, Czech Republic Official(s) and/or principal investigator(s): Jan Blaha, MD, PhD, Principal Investigator, Affiliation: Charles University, Prague
Overall contact: Jan Blaha, MD, Ph.D., Email: jan.blaha@vfn.cz
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Induction to delivery interval
Secondary outcome: Time of surgerySurgical conditions index (SCi) Peroperative and postoperative surgical complication Need for respiratory support
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Jan Blaha, MD, Ph.D., Email: jan.blaha@vfn.cz
General University Hospital in Prague, Prague, Czech Republic; Recruiting Jan Blaha, MD, PhD., Principal Investigator
Additional Information
Starting date: February 2013
Last updated: January 29, 2014
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