Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

NCT00451100 | Completed Phase 3

• 3 other identifiers: P05931Crystal Trial19.4.310
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9

  After surgery

Secondary Outcomes (2)

• Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8

  After surgery

• Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)

  after surgery

Study Arms (2)

Sugammadex

EXPERIMENTAL

2.0 mg/kg Org 25969 (sugammadex)

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

50 ug/kg neostigmine

Drug: neostigmine

Interventions

Sugammadex DRUG

Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered

Also known as: Org 25969

Sugammadex

neostigmine DRUG

Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered

Also known as: premix neostigmine/glycopyrrolate

Neostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 18385265 RESULT

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: November 10, 2005
• Primary Completion: May 22, 2006
• Study Completion: August 29, 2006
• Last Updated: November 15, 2019

Record last verified: 2019-11