Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

December 31, 2013

Conditions
Neuromuscular Blockade
Interventions
DRUG

Sugammadex

50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC\<2).

DRUG

Neostigmine

50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC\<2).

Trial Locations (1)

30120

Mª Dolores Cárceles Barón, El Palmar

All Listed Sponsors
collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

collaborator

Hospital Universitario Santa Maria del Rosell

UNKNOWN

lead

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

NCT01809886 - Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial | Biotech Hunter | Biotech Hunter