Reversal of rocuronium with sugammadex at low doses

Conditions: euromuscular 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: 14.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10029315Term: Neuromuscular blockadeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-002362-39-ES

Lead Sponsor: Consorci Mar Parc de Parc de Salut de Barcelona (Parc de Salut MAR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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 <80 ml/ min or serum creatinine more than 1.8 mg / dl).
6. Liver disease (liver function tests with more than 50% above normal values).
7. History of difficult intubation, difficult intubation rates (Mallampatti> 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.