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

NCT01941628 | Completed Phase 4 Results DMC

• 2 other identifiers: RocSuc2013-003077-97
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section

Keywords

Cesarean section; General anesthesia; neuromuscular blockade; Surgical conditions

Outcome Measures

Primary Outcomes (2)

• Induction to Delivery Interval

  Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.

  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.

  24 hours

Secondary Outcomes (1)

• Peroperative and Postoperative Surgical Complication

  5 days

Study Arms (2)

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.

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.

Drug: Succinylcholine

Interventions

Rocuronium DRUG

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.

Rocuronium

Succinylcholine DRUG

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.

Succinylcholine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• lost to follow up
• the investigator feels that it's in the subject's best interest to discontinue the study

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, Czechia

Location

MeSH Terms

Interventions

Rocuronium; Succinylcholine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Results Point of Contact

• Title: Assoc. Prof. Jan Blaha, MD, PhD
• Organization: Dept. of Anaesthesiology and Intensive Medicine, General University Hospital in Prague

jan.blaha@lf1.cuni.cz

+420 224962243

Study Officials

• Jan Blaha, MD, PhD

  Charles University, Prague

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-chair of the Department

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: August 16, 2014
• Primary Completion: December 30, 2016
• Study Completion: April 3, 2018
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2019-02

Locations

CZ (1)