NCT01101139

Brief Summary

This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

April 8, 2010

Last Update Submit

December 14, 2012

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Muscle function

    Muscle function following the investigational drug

Study Arms (2)

Experimental

EXPERIMENTAL

Single injection of Sugammadex 0.25 mg/kg

Drug: Sugammadex

Placebo comparator

PLACEBO COMPARATOR

Single injection of Saline 0.9%

Drug: Placebo

Interventions

SugammadexDRUG

Sugammadex (single intravenous injection 0.25 mg/kg)

Experimental
PlaceboDRUG

Placebo: single intravenous injection Saline 0.9%

Placebo comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical stauts II - III
  • Age: 18 - 65 years
  • Patients scheduled for general anesthesia with intubation using rocuronium
  • Patients have given informed consent to the study
  • Patients receiving the investigational drug within 15 minutes after neuromuscular recovery to a TOF 0.9
  • Sufficient knowledge of the German language

You may not qualify if:

  • known or suspected neuromuscular disease
  • significant hepatic or renal dysfunction
  • known or suspected history or family history of disposition to malignant hyperthermia
  • known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
  • Use o drugs that interfere with sugammadex
  • Patients included in another trial within the last 30 days
  • Patients with legal guidant
  • Patients with contradiction towards the use of Sugammadex
  • Pregnant women
  • Breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anaesthesiologie Klinikum München rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Related Publications (5)

  • Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.

    PMID: 9366929BACKGROUND

  • Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.

    PMID: 18635478BACKGROUND

  • Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.

    PMID: 18648227BACKGROUND

  • Waud DR, Waud BE. In vitro measurement of margin of safety of neuromuscular transmission. Am J Physiol. 1975 Dec;229(6):1632-4. doi: 10.1152/ajplegacy.1975.229.6.1632.

    PMID: 1211496BACKGROUND

  • Baumuller E, Schaller SJ, Chiquito Lama Y, Frick CG, Bauhofer T, Eikermann M, Fink H, Blobner M. Postoperative impairment of motor function at train-of-four ratio >/=0.9 cannot be improved by sugammadex (1 mg kg-1). Br J Anaesth. 2015 May;114(5):785-93. doi: 10.1093/bja/aeu453. Epub 2015 Jan 13.

    PMID: 25586724DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Manfred Blobner, M.D.

    Klinik für Anaesthesiologie Klinikum München rechts der Isar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

April 9, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

DE(1)