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

NCT ID: NCT00379613

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-07
• Study Completion Date: 2004-07-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

rocuronium + 16.0 mg/kg Org 25969

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

2

rocuronium + 2.0 mg/kg Org 25969

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: 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

3

rocuronium + 4.0 mg/kg Org 25969

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: 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

4

rocuronium + 8.0 mg/kg Org 25969

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: 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

5

rocuronium + 12.0 mg/kg Org 25969

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: 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

Interventions

sugammadex

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Org 25969

Eligibility Criteria

Inclusion Criteria

• 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

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 17667567 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

19.4.205

Identifier Type: -

Identifier Source: secondary_id

P05942

Identifier Type: -

Identifier Source: org_study_id