Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00895609
Other study ID # SUNDRO
Secondary ID
Status Completed
Phase Phase 4
First received April 29, 2009
Last updated March 18, 2013
Start date March 2009
Est. completion date August 2009

Study information

Verified date March 2013
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 99
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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 ß- HCG screen, status post tubal ligation)

- Breastfeeding women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München Munic Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2. — View Citation

Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee. — View Citation

Pühringer FK, Rex C, Sielenkämper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to TOF-ratio 0.9 following the investigational drug Regular anesthesia time, approximately 1 hour
See also
  Status Clinical Trial Phase
Completed NCT02484651 - Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade? Phase 4
Completed NCT01440933 - Efficacy of Sugammadex in Magnesium Pretreated Patients Phase 2
Recruiting NCT02778945 - Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery Phase 4
Recruiting NCT02966249 - Dexmetomidine Intrathecally and Intravenously Additionally to Spinal Anaesthesia, in Total Knee Arthroplasty Phase 4
Completed NCT02838134 - Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery Phase 4
Completed NCT03734250 - D Vitamin Effects on Neuromuscular Blocker Reverse Time
Not yet recruiting NCT03287388 - MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy N/A
Completed NCT01791036 - Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair N/A
Not yet recruiting NCT02648503 - Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy Phase 4
Completed NCT02483611 - Effects of Intravenous Lidocaine Associated With Magnesium Sulfate on the Cisatracurium-Induced Neuromuscular Block Phase 4
Completed NCT02320734 - Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy Phase 4
Recruiting NCT05005676 - Evaluation of the New Acceleromyograph TOF 3D N/A
Not yet recruiting NCT03460509 - Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery Phase 4
Completed NCT00828373 - The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium Phase 4