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Sugammadex and Neostigmine at Shallow Neuromuscular Blockade (SUNDRO)

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ClinicalTrials.gov Identifier: NCT00895609
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : March 19, 2013
Sponsor:
Information provided by:
Technische Universität München

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE May 8, 2009
Last Update Posted Date March 19, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
Time to TOF-ratio 0.9 following the investigational drug [ Time Frame: Regular anesthesia time, approximately 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
Official Title  ICMJE Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.5)
Brief Summary This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.
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 anesthetist 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 gamma-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 0.5) with different doses of either the neostigmine or sugammadex.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuromuscular Block
Intervention  ICMJE Drug: Sugammadex, Neostigmine, Saline

Single intravenous injection of either:

Sugammadex 0.0625 mg/kg (Sgx 0.0625) Sugammadex 0.125 mg/kg (Sgx 0.125) Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 1.0 mg/kg (Sgx 1.0) Neostigmine 5 mg/kg (Neo 5) Neostigmine 8 mg/kg (Neo 8) Neostigmine 15 mg/kg (Neo 15) Neostigmine 25 mg/kg (Neo 25) Neostigmine 40 mg/kg (Neo 40) Saline 0.9% (Saline)

Study Arms  ICMJE
  • Experimental: Sugammadex
    Sugammadex in doses: 0 (placebo), 0.0625, 0.125, 0.25, 0.5 and 1 mg/kg
    Intervention: Drug: Sugammadex, Neostigmine, Saline
  • Active Comparator: Neostigmine
    Neostigmine in doses: 0 (placebo), 5, 8, 15, 25, 40 mg/kg
    Intervention: Drug: Sugammadex, Neostigmine, Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2012)
99
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ASA physical status I - III
  • Patients between 18 and 64 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00895609
Other Study ID Numbers  ICMJE SUNDRO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manfred Blobner, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
PRS Account Technische Universität München
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP