Neuromuscular blockade is induced during general anesthesia, which often does not recover spontaneously, so it is necessary a pharmacological reversal. We believe that sugammadex at lower doses than those recommended by the technical datashet is useful for antagonizing rocuronium neuromuscular blockade during general anesthesia, although this effect is expected to be slower. MedDRA version: 14.1 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 100
Conditions
Interventions
Trade Name: Bridion
Sugammadex
EMEA/H/C/000885
Product Name: Bridion
Product Code: 08466001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sugammadex
CAS Number: 343306-79-6
Other de
Sponsors
Consorci Mar Parc de Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged more than 18. 2. Patients with inform consent signed indicating that they have been informed of all pertinent aspects of the trial. 3. Patients scheduled for laparoscopic cholecystectomy Intervention. 4. Negative pregnancy test in the two weeks before the start of treatment (serum) in all women of childbearing age. Postmenopausal women have amenorrhea for at least 12 months to consider that are not of childbearing age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have refused to sign the consent form. 2. Patients with presence of an underlying neuromuscular disease. 3. Patients in whom the use of drugs known to interfere with neuromuscular transmission (anticonvulsants or aminoglycosides). 4. Patients with evidence or medical or surgical history relevant for the study. 5. Patients with severe-moderate renal insufficiency (creatinine clearance > or equal to 30 to 3 thyromental Distance less than 7 and buccal overture <7 cm), which may be advised to use another anesthetic technique. 8. Patients with hypersensitivity to the active substance or to any of the excipients as indicated sugammadex data sheet. 9. Pregnant People who do not use contraceptives and effective means lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study of lower doses versus standard doses equivalence in the reversal of neuromuscular blockade induced by rocuronium bromide. The dose recommended by the data sheet of sugammadex can be reduced up to 50% without losing efficacy in the reversal of neuromuscular blockade induced by rocuronium bromide in general anesthesia.;Secondary Objective: 1.Establish decreasing sugammadex cost by reducing 50% of the recommended dose. One vial of sugammadex costs 70 euros, it requires 1-5 vials to reverse neuromuscular blockade of rocuronium bromide, depending on the depth. Is expected to decrease the economic cost of sugammadex 50%. 2.Check that although the time required to reverse the neuromuscular blockade of rocuronium bromide with sugammadex will be higher by reducing the dose recommended by the data sheet by 50%, this increase will not be clinically relevant.;Primary end point(s): Percentage of patients who are antagonized neuromuscular blockade with half dose recommended by the technical datasheet of sugammadex.;Timepoint(s) of evaluation of this end point: The time required to determine the effectiveness of half the dose recommended by the data sheet of sugammadex is produced in the same operating room. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Increasing the time to reach a TOF ratio of 0.9 with half the dose recommended by the manufacturer. Financial savings this AmB.;Timepoint(s) of evaluation of this end point: The time required to determine if half of the dose recommended by the manufacturer time increases but recovery of neuromuscular blockade reduces costs is obtained at the end of the study. | — |
Countries
Spain
Contacts
Public ContactFernando Escolano
Hospital del Mar, Servicio de Anestesiología, Reanimación y Terapia del Dolor
Outcome results
None listed