Sugammadex and Neostigmine at Shallow Neuromuscular Blockade (SUNDRO)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00895609
First received: April 29, 2009
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Neuromuscular Block
Drug: Sugammadex, Neostigmine, Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.5)

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 hour ]

Enrollment: 99
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugammadex
Sugammadex in doses: 0 (placebo), 0.0625, 0.125, 0.25, 0.5 and 1 mg/kg
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)

Active Comparator: Neostigmine
Neostigmine in doses: 0 (placebo), 5, 8, 15, 25, 40 mg/kg
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)


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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00895609

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: Manfred Blobner, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00895609     History of Changes
Other Study ID Numbers: SUNDRO
Study First Received: April 29, 2009
Last Updated: March 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Residual neuromuscular block
post-operative residual curarization
PORC
sugammadex
neostigmine
Shallow neuromuscular block (TOF-ratio of 0.5)

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 July 23, 2014