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Sugammadex and Neostigmine at Residual Neuromuscular Blockade

Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01006720
Acronym
SUNDRO20
Enrollment
99
Registered
2009-11-03
Start date
2009-03-31
Completion date
2009-12-31
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual Neuromuscular Block (TOF-ratio of 0.2)

Keywords

Residual neuromuscular block, post-operative residual curarization, PORC, sugammadex, neostigmine

Brief summary

This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) 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 anesthesiologist 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 γ-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 0.2) with different doses of either the neostigmine or sugammadex.

Interventions

DRUGSugammadex

Single intravenous injection of either: Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)

DRUGNeostigmine

Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)

DRUGSaline

Saline 0.9% (Saline)

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ASA physical status I - III * Patients over 18 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

Design outcomes

Primary

MeasureTime frame
Time to TOF-ratio 0.9 following the investigational drugRegular anesthesia time, approximately 1.5 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026