Sugammadex and Neostigmine at Residual Neuromuscular Blockade (SUNDRO20)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01006720
First received: November 2, 2009
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex.


Condition Intervention
Residual Neuromuscular Block (TOF-ratio of 0.2)
Drug: Sugammadex
Drug: Neostigmine
Drug: Saline

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2)

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Time to TOF-ratio 0.9 following the investigational drug [ Time Frame: Regular anesthesia time, approximately 1.5 hours ]

Enrollment: 99
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sgx 0.25
Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade
Drug: Sugammadex

Single intravenous injection of either:

Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

Sgx 0.5
Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade
Drug: Sugammadex

Single intravenous injection of either:

Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

Sgx 0.75
Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade
Drug: Sugammadex

Single intravenous injection of either:

Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

Sgx 1.0
Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade
Drug: Sugammadex

Single intravenous injection of either:

Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

Sgx 1.25
Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade
Drug: Sugammadex

Single intravenous injection of either:

Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

Neo 10
Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade
Drug: Neostigmine
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
Neo 25
Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade
Drug: Neostigmine
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
Neo 40
Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade
Drug: Neostigmine
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
Neo 55
Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade
Drug: Neostigmine
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
Neo 70
Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade
Drug: Neostigmine
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
Saline
Saline group: Saline as placebo
Drug: Saline
Saline 0.9% (Saline)

Detailed Description:

Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e. post-operative residual curarization: PORC). Reportedly about 30% of all patients who received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit. PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration after extubation. Possible deleterious effects of this could be pneumonia, bronchitis, myocardial infarction, cardiac insufficiency, stroke or re-operation.

In order to avoid PORC patients with residual neuromuscular block receive a muscle relaxant antagonist from the anesthesiologist at the end of the operation. However, these drugs (neostigmine, pyridostigmine, etc.) from the class of cholinesterase inhibitors have unwanted effects such as bradycardia, increased gastro-intestinal motility, post-operative nausea and vomiting, salivation etc. To decrease these unwanted side effects cholinesterase inhibitors have to be given in combination with parasympatholyics e.g. atropine or glycopyrrolate with their own spectrum of unwanted side effects.

From October 2008 on, Sugammadex, a completely new reversal drug was introduced in to clinical practice. Sugammadex, is a modified γ-cyclodextrine able to specifically bind rocuronium (a steroidal muscle relaxant). The complex is eliminated via the kidneys. However, all studies so far have focussed on reversal of profound or deep neuromuscular blockade. This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either the neostigmine or sugammadex.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients receiving rocuronium for neuromuscular blockade under general anesthesia

Criteria

Inclusion Criteria:

  • Patients ASA physical status I - III
  • Patients over 18 years
  • Patients scheduled for general anesthesia with intubation using rocuronium
  • Patients having given informed consent to the study

Exclusion Criteria:

  • Anatomic and functional malformations with expected difficult intubation
  • Known or suspected neuromuscular disease
  • Significant hepatic or renal dysfunction
  • Known or suspected history or family history of disposition to malignant hyperthermia
  • Known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
  • Use of drugs that interfere with muscle relaxants
  • Patients, included in another trial within the last 30 days
  • Patients, with legal guidant
  • Patients with contraindication towards the use of Sugammadex, neostigmine or glycopyrrolate
  • Patients, which have already participated in a sugammadex trial
  • Pregnant women (exclusion of pregnancy: postmenopausal status, negative β- HCG screen, status post tubal ligation)
  • Breastfeeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006720

Locations
Germany
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Heidrun Fink, PD Dr., MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
  More Information

Publications:
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01006720     History of Changes
Other Study ID Numbers: SUNDRO20, EudraCT number 2009-013499-29
Study First Received: November 2, 2009
Last Updated: December 12, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Residual neuromuscular block
post-operative residual curarization
PORC
sugammadex
neostigmine

Additional relevant MeSH terms:
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014