Reducing the dose of sugammadex 50% reverse the neuromuscular blockade of rocuronium effectively after general anesthesia.

INTERVENTION: 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 descriptive name: SUGAMMADEX Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 1‐4 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 descriptive name: SUGAMMADEX Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 2‐8 CONDITION: 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: 10042613 ‐ Surgical and medical procedures ; MedDRA version: 14.1 Level: PT Classification code 10029315 Term: Neuromuscular blockade System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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. Primary end point(s): Percentage of patients who are antagonized neuromuscular blockade with half dose recommended by the technical datasheet of sugammadex. 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. 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 OUTCOME: 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. 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