Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

NCT00379613 | Completed Phase 2 DMC

• 2 other identifiers: P0594219.4.205
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.

  After administration of rocuronium

Secondary Outcomes (1)

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.

  After administration of rocuronium

Study Arms (5)

1

PLACEBO COMPARATOR

rocuronium + 16.0 mg/kg Org 25969

Drug: Placebo

2

EXPERIMENTAL

rocuronium + 2.0 mg/kg Org 25969

Drug: sugammadex

3

EXPERIMENTAL

rocuronium + 4.0 mg/kg Org 25969

Drug: sugammadex

4

EXPERIMENTAL

rocuronium + 8.0 mg/kg Org 25969

Drug: sugammadex

5

EXPERIMENTAL

rocuronium + 12.0 mg/kg Org 25969

Drug: sugammadex

Interventions

sugammadex DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

Also known as: Org 25969

2; 3; 4; 5

Placebo DRUG

After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

1

Eligibility Criteria

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

You may qualify if:

• ASA 1 - 2 between the ages of 18 and 64, inclusive
• Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
• Scheduled for surgery 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 known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
• Subjects who had already participated in CT 19.4.205
• Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
• Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
• Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (\>6 months), IUD, abstinence
• Subjects giving breast-feeding

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• de Boer HD, Driessen JJ, Marcus MA, Kerkkamp H, Heeringa M, Klimek M. Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. Anesthesiology. 2007 Aug;107(2):239-44. doi: 10.1097/01.anes.0000270722.95764.37.

  PMID: 17667567 RESULT

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: November 7, 2003
• Primary Completion: July 14, 2004
• Study Completion: July 14, 2004
• Last Updated: August 22, 2017

Record last verified: 2017-08