Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
- Conditions
- Neuromuscular Block
- Interventions
- Drug: Sugammadex, Neostigmine, Saline
- Registration Number
- NCT00895609
- Lead Sponsor
- Technical University of Munich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugammadex Sugammadex, Neostigmine, Saline Sugammadex in doses: 0 (placebo), 0.0625, 0.125, 0.25, 0.5 and 1 mg/kg Neostigmine Sugammadex, Neostigmine, Saline Neostigmine in doses: 0 (placebo), 5, 8, 15, 25, 40 mg/kg
- Primary Outcome Measures
Name Time Method Time to TOF-ratio 0.9 following the investigational drug Regular anesthesia time, approximately 1 hour
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
🇩🇪Munic, Bavaria, Germany