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OpenTrials
Completed

NCT Number: NCT00451100

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Org 25969

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

Other names: premix neostigmine/glycopyrrolate

Primary outcomes

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

    Time frame: After surgery

Secondary outcomes

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

    Time frame: After surgery

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

    Time frame: after surgery

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 23, 2007
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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