Neuromuscular Blockade induced by Rocuronium MedDRA version: 14.0 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: BRIDION 100 mg/ml solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SUGAMMADEX SODIO
Other descriptive name: SUGAMMADEX SODIO
Concentration unit: mg/ml m
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children of both sexes, aged between two and eleven years will have surgery for procedures of short duration (less than one hour) and requiring muscle relaxation. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Express their wish not to participate in the trial - Patients with anticipated difficult airway - Patients with Neuromuscular disease-present -Liver failure and / or renal -Have personal or family history of malignant hyperthermia, -Submitted previous allergic reaction to any anesthetic. -On treatment at the time of the study with aminoglycosides, magnesium, anticonvulsants, toremifene, Flucloxacillin and Fusidic Acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of the reversal with Sugammadex from deep neuromuscular blockade induced and maintained with rocuronium in pediatric patients scheduled for elective surgery and short duration and the reversal with neostigmine.;Secondary Objective: To compare the residual relaxation over neostigmine. -Compare the neostigmine-induced electrocardiographic changes regarding the possible occurrence of the same with sugammadex. -Assess vital signs (respiratory rate, blood pressure, heart rate, body temperature, body weight, body mass index, etc.).. -Compare the length of stay in intensive care with two blocking regimens. -To compare the immediate postoperative morbidity. -Assess the number of withdrawal of patients in both groups (dropout). -Record the necessary concomitant.;Primary end point(s): Efficacy Variable: The time in seconds elapsed since the administered dose of 4 mg / kg sugammadex or neostigmine and atropine (0.05 mg.kg and 0.025 mg/kg )until you get a T4/T1 ratio> 0.9 (Both groups). Safety variable:Profile of adeverse events in both groups;Timepoint(s) of evaluation of this end point: At the end of the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical and hemodynamic intra-operative and post-operative monitoring (15, 30, 45, 50 and 60 min after reversal drug) - Rhythm and Heart Rate (beats / min), ECG. -Systolic blood pressure (mm Hg) - Diastolic blood pressure (mm Hg) - Arterial oxygen saturation (%) - Total dose of rocuronium. • Monitoring of neuromuscular function (TOF-Watch) -Time, in seconds, from the initial dose administered of rocuronium until the maximum block is achieved (Onset time) -The time in seconds which elapses after the administration of 4 mg / kg dose of sugammadex or neostigmine 0.05 mg.kg and atropine 0.025 mg.kg until a T4/T1 > 0.8.ratio is achieved -The time in seconds which elapses from the administered dose of 4 mg / kg of sugammadex or neostigmine 0.05 mg.kg and atropine 0.025 mg.kg until a T4/T1 > 0.7. ratio is achieved - T2 Recovery time after Sugammadex - Comeback time T3 after Sugammadex - Comeback time T4 after Sugammadex - Time to extubation after Sugammadex Clinical course: 1. Subjective level of consciousness: A. Awake and oriented B. Waking up with minimal stimulation. C. Responds only to tactile stimulation. 2. Can cooperate? No / Yes 3. Can keep the head up for 5 seconds? No / Yes 4. Muscle weakness? No / Yes 5. Length of stay in Recovery Unit;Timepoint(s) of evaluation of this end point: After experimental treatment | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
Fundación para la Formación e Investigación Sanitarias dela Región de Murcia
Outcome results
None listed