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Trial record 8 of 187 for:    Open Studies | "Cesarean Section"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Charles University, Czech Republic
Sponsor:
Collaborator:
General University Hospital, Prague
Information provided by (Responsible Party):
Jan Blaha, MD, PhD., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01941628
First received: September 5, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cesarean Section
Drug: Rocuronium
Drug: Succinylcholine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Induction to delivery interval [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.


Secondary Outcome Measures:
  • Time of surgery [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Time of surgery will be used to compare influence of deep versus no/shallow muscular blockade during the entire Cesarean section on surgical conditions for suture of the uterus and the abdominal wall.

  • Surgical conditions index (SCi) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

    Surgical conditions index (SCi) will be used to evaluate surgical peroperative conditions. SCi is based on the sum of a five-point scale evaluations (1-5; excellent - above average - average - below average - poor) of the following parameters:

    • relaxation of mm. recti abdomini
    • subjective evaluation of delivery interval
    • easiness of fetus delivery
    • visualization of the internal organs
    • accessibility to the abdominal cavity
    • easiness of abdominal wall suture
    • overall surgical conditions thorough the surgery

  • Peroperative and postoperative surgical complication [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Surgical complications (total number and severity) will be evaluated at day 5 after Cesarean delivery.

  • Need for respiratory support [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    The primary safety objective:

    Need for respiratory support will be the primary safety measure in comparison of the influence of different neuromuscular blockade levels on newborn adaptation.



Other Outcome Measures:
  • Rocuronium plasma levels in mother [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Rocuronium plasma levels in mother will be sampled at the time of intubation, fetus delivery and at the time 1, 3, 15, 30, 45, 60 and 120 min after administration of sugammadex

  • Rocuronium plasma levels in cord blood [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Rocuronium plasma level in cord blood will be sampled at the time of fetus delivery.

  • Sugammadex plasma levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Sugammadex plasma levels will be sampled 1, 3 and 15 min after its administration. Urine will be sampled 12 hours after sugammadex administration


Estimated Enrollment: 45
Study Start Date: February 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rocuronium
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.
Drug: Rocuronium
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.
Active Comparator: Succinylcholine
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.
Drug: Succinylcholine
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941628

Contacts
Contact: Jan Blaha, MD, Ph.D. jan.blaha@vfn.cz

Locations
Czech Republic
General University Hospital in Prague Recruiting
Prague, Czech Republic
Principal Investigator: Jan Blaha, MD, PhD.         
Sponsors and Collaborators
Charles University, Czech Republic
General University Hospital, Prague
Investigators
Principal Investigator: Jan Blaha, MD, PhD Charles University, Prague
  More Information

No publications provided

Responsible Party: Jan Blaha, MD, PhD., Vice-chair of the Department, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01941628     History of Changes
Other Study ID Numbers: RocSuc, 2013-003077-97
Study First Received: September 5, 2013
Last Updated: January 29, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Charles University, Czech Republic:
Cesarean section
General anesthesia
neuromuscular blockade
Surgical conditions

Additional relevant MeSH terms:
Anesthetics
Rocuronium
Succinylcholine
Central Nervous System Agents
Central Nervous System Depressants
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Neuromuscular Nondepolarizing Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014