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

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ClinicalTrials.gov Identifier: NCT00379613
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: sugammadex Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 7, 2003
Actual Primary Completion Date : July 14, 2004
Actual Study Completion Date : July 14, 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [ Time Frame: After administration of rocuronium ]

Secondary Outcome Measures :
  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. [ Time Frame: After administration of rocuronium ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00379613     History of Changes
Other Study ID Numbers: P05942
19.4.205
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs