Sugammadex and Neostigmine at Shallow Neuromuscular Blockade (SUNDRO)

Technical University of Munich

Status and phase

Completed

Phase 4

Conditions

Neuromuscular Block

Treatments

Drug: Sugammadex, Neostigmine, Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00895609

SUNDRO

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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