Clinical trial NCT00451100: Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)
Official title: Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2


Eligibility criteria: Inclusion Criteria:

* Subjects of ASA 1 - 4;
* Subjects above or equal to the age of 18;
* Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium;
* Scheduled for surgical procedures in supine position;
* Given written informed consent.

Exclusion Criteria:

* Subjects in whom a difficult intubation because of anatomical malformations was expected;
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
* Subjects known or suspected to have a (family) history of malignant hyperthermia;
* Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
* Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Subjects who had already participated in an Org25969 trial;
* Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310.
* Female subjects who are pregnant:
* Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
* Female subjects who were breast -feeding.

Primary outcomes:
measure: Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9
timeFrame: After surgery
Secondary outcomes:
measure: Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8
timeFrame: After surgery
measure: Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)
timeFrame: after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.