Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)(COMPLETED)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anesthesia, General |
Drug: sugammadex Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron |
- Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [ Time Frame: After administration of rocuronium ] [ Designated as safety issue: No ]
- 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. [ Time Frame: After administration of rocuronium ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2003 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
rocuronium + 16.0 mg/kg Org 25969
|
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 |
|
Experimental: 2
rocuronium + 2.0 mg/kg Org 25969
|
Drug: 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 Other Name: Org 25969
|
|
Experimental: 3
rocuronium + 4.0 mg/kg Org 25969
|
Drug: 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 Other Name: Org 25969
|
|
Experimental: 4
rocuronium + 8.0 mg/kg Org 25969
|
Drug: 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 Other Name: Org 25969
|
|
Experimental: 5
rocuronium + 12.0 mg/kg Org 25969
|
Drug: 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 Other Name: Org 25969
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00379613 History of Changes |
| Other Study ID Numbers: | 19.4.205 |
| Study First Received: | September 21, 2006 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Additional relevant MeSH terms:
|
Rocuronium Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013