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Completed

NCT Number: NCT02054468

Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol Anesthesia

This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

About this study

Neuromuscular blocking agents are worldwide used as a standard component of a modern balanced anesthesia regime. They are administered to facilitate tracheal intubation, reduce laryngeal trauma and optimize surgical conditions. The dose usually recommended to facilitate tracheal intubation approximates at least two times the drug´s effective dose ED-95 (the dose required for a 95% effect) depending on the choice of the neuromuscular blocking agent. This overdose is administered to induce a very deep paralysis with a fast onset of action providing clinically acceptable intubating conditions. Moreover, our clinical experience has shown that the dose-relationship of a neuromuscular blocking agents estimated during steady-state anesthesia does not necessarily correlate with the dose-response curve of the same drug during anesthetic induction. Therefore, a discrepancy between the applied dose and the clinical outcome measure, the intubating conditions, becomes apparent. This might be related to effects of the co-administered anesthetics at the neuromuscular junction. While inhaled anesthetics augment the paralyzing effects of non-depolarizering muscle relaxants in a dose-dependent fashion and depend on the duration of anesthesia, little is known about the interactions of the intravenous anesthetic propofol with the non-depolarizing blocking agent rocuronium. We hypothesize that the intravenous administration of propofol also influences the potency of rocuronium dependant on the duration of its application.

This study, therefore, is designed to determine the dose-response relationship of rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting. The primary endpoints are the ED-50s and ED-95s of rocuronium during anesthetic induction with a single-shot propofol and after 30minutes of steady-state propofol anesthesia. The secondary endpoints are the slopes and the intercepts of the respective dose-response-curves, the onset and duration of muscle paralysis and the recovery from neuromuscular blockade.

Materials & Methods

We will investigate patients scheduled for elective low-risk surgical procedures under general anesthesia. Patients will be allocated to two experimental groups. After neuromuscular monitoring is established under remifentanil infusion, patients of the group "Induction" will receive a single-shot propofol followed by injection of rocuronium and endotracheal intubation. Patients of the group "Maintenance" will be anaesthetized with an induction dose of propofol followed by 30 minutes of total intravenous anesthesia (TIVA: propofol/ remifentanil) before rocuronium is administered. Airway will be managed using a laryngeal mask or tracheal intubation.

During surgery, anesthesia will be maintained with TIVA. Onset and duration of neuromuscular blockade and spontaneous recovery will be monitored with electromyography.

Postoperatively, patients will be monitored for 60 minutes in our post-anesthesia care unit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for a low risk-surgical procedure under general anesthesia
  • Patients ASA physical status I-III
  • Patients older than 18years
  • Patients having given informed consent to the study

Exclusion criteria

  • Patients who decline to give informed consent to the study
  • Known or suspected allergy towards anesthetics or rocuronium
  • Pregnant and breastfeeding women
  • Known or suspected neuromuscular disease
  • Burn injury prior to the investigation
  • Anatomic and functional malformations with expected difficult intubation
  • Anorexia, Bulimia nervosa, Malnutrition
  • Heart failure
  • Use of drugs that interfere with muscle relaxant

Treatment and study plan

Single-Shot Propofol

Drug

Single-shot propofol induction dose (1.5-2.5mg/kg body mass)

Other names: 2,6-Diisopropylphenol

30min infusion Propofol

Drug

30min of propofol infusion (4-6mg/kg/h)

Other names: 2,6-Diisopropylphenol

Remifentanil infusion

Drug

Remifentanil infusion (0.1-0.2µg/kg/min)

Other names: Ultiva®

Rocuronium (0.07mg/kg/body mass)

Drug

Rocuronium (0.07mg/kg/body mass)

Other names: Esmeron

Rocuronium (0.1mg/kg/body mass)

Drug

Rocuronium (0.1mg/kg/body mass)

Other names: Esmeron

Rocuronium (0.15mg/kg/body mass)

Drug

Rocuronium (0.15mg/kg/body mass)

Other names: Esmeron

Rocuronium (0.2mg/kg/body mass)

Drug

Rocuronium (0.2mg/kg/body mass)

Other names: Esmeron

Rocuronium (0.3mg/kg/body mass)

Drug

Rocuronium (0.3mg/kg/body mass)

Other names: Esmeron

Rocuronium (0.45mg/kg/body mass)

Drug

Rocuronium (0.45mg/kg/body mass)

Other names: Esmeron

Primary outcomes

  1. ED-50 of rocuronium

    Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

    The primary outcome measure is the 1) ED-50 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia

  2. ED-95 of rocuronium

    Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

    The primary outcome measure is 2) the ED-95 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia

Secondary outcomes

  1. Pharmacodynamics of rocuronium (composite outcome measure)

    Time frame: Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

    The secondary outcome measures are the slopes and the intercepts of the dose-response-curves for rocuronium, the onset and duration of muscle paralysis and the recovery from neuromuscular blockade.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol

Acronym: ROSANNA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2014
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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