Overview

Sugammadex and Neostigmine at Shallow Neuromuscular Blockade

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Technische Universität München
Treatments:
Neostigmine
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