MedTrace Logo

Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)

NCT00826176 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2015-10-07

Study results available
· View outcomes & findings →

Summary

The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.

Conditions

  • Anesthesia, General
  • Neuromuscular Blockade

Interventions

DRUG

Sugammadex

After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-08-31
Completion
2010-08-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826176 on ClinicalTrials.gov