Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

NCT ID: NCT00656799

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-07-31

Brief Summary

The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

Detailed Description

The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sugammadex

IV single bolus dose of 4.0 mg/kg sugammadex

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.

Rocuronium

Intervention Type: DRUG

After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered

Interventions

sugammadex

At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.

Intervention Type: DRUG

Rocuronium

After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered

Intervention Type: DRUG

Other Intervention Names

Org 25969; SCH 900616; MK-8616; Bridion®; Rocuronium bromide; Esmeron®

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• American Society of Anesthesiologists (ASA) Class >=4
• Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis
• Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
• Scheduled for a (surgical) procedure in supine position
• Written informed consent (of the legal representative)

Exclusion Criteria

• Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
• Known or suspected to have a (family) history of malignant hyperthermia
• Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Have already participated in a sugammadex trial
• Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
• Females who are pregnant*
• Females who are breast-feeding * In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Cammu G, Van Vlem B, van den Heuvel M, Stet L, el Galta R, Eloot S, Demeyer I. Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment. Br J Anaesth. 2012 Sep;109(3):382-90. doi: 10.1093/bja/aes207. Epub 2012 Jun 24.

Reference Type: RESULT

PMID: 22732111 (View on PubMed)

Other Identifiers

2007-006934-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05773

Identifier Type: -

Identifier Source: org_study_id