Time of a TOF Ratio >0,9 Clinical Trial
Official title:
Minimal Optimal Dose of Sugammadex in Elective Surgery
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex
Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion
criteria: women and men> 18 years old, elective surgery, BMI <30, patients giving consent to
free and informed participation in writing;
Exclusion criteria:
- minor patients;
- Patients refusing to sign the consent;
- Patients included in another protocol within 3 months;
- Pregnant or lactating patients;
- Patients with a history of allergy to Sugammadex;
- Patients with known neuromuscular disease;
- Patients with renal or hepatic impairment.
Course of the study :
- 40 patients will be recruited at the time of the anesthesia consultation and randomized
to double blind in 8 groups (the day before surgery)
- All patients will benefit from general anesthesia. Anesthetic management
(1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and
maintenance anesthesia with sevoflurane) will be standardized for all patients.
- Upon administration of rocuronium the acceleromyography transducer will be attached to
the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the
ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued
until the end of the anesthesia.
- Once the first answer (1st twitch) appeared a dose of sugammadex will be administered
according to the group whose patient was randomized: Test Groups Control Groups Group 1:
Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5
mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg +
TOF 1 Group 4bis: 2mg / kg + TOF 2
- Then a standard dose of 4mg / kg will be administered at the end of the procedure before
awakening to all patients who have signs of residual curarization (TOF ratio <0.9). The
pharmacy will be responsible for preparing the different doses of sugammadex, the
syringe will be carefully covered and packaged, will contain an equal volume so that the
anesthetists do not know which group the patient belongs to. Data collection: In real
time during the intervention by the anesthesiologist in charge of patient Method of
Analysis: Analysis of intent-to-treat data
;