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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451100
• Other study ID #: P05931
• Secondary ID: Crystal Trial19.
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2005
• Est. completion date: August 29, 2006

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 29, 2006
• Est. primary completion date: May 22, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• Sugammadex
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
• neostigmine
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9		After surgery
Secondary	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8		After surgery
Secondary	Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)		after surgery

External Links

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