Minimal Optimal Dose of Sugammadex in Elective Surgery

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Time of a TOF Ratio >0,9

Treatments: Drug: Sugammadex Injection [Bridion]

Study type: Interventional

Funder types: Other

Identifiers

NCT03515694

BRIDION_ERASME

Details and patient eligibility

About

Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

women and men> 18 years of age Elective Surgery BMI <30, patients who gave consent to free and informed participation in writing

Exclusion criteria

• minor patients;
• patients refusing to sign consent;
• patients included in another protocol within 3 months;
• pregnant or nursing patients;
• patients with a history of allergy to Sugammadex;
• patients with known neuromuscular disease
• patients with renal or hepatic impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 8 patient groups, including a placebo group

Dose of 0mg/kg TOF1

Placebo Comparator group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 0mg/kg TOF2

Placebo Comparator group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 0 ,5mg/kg TOF1

Experimental group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 0,5mg/kg TOF2

Active Comparator group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 1mg/kg TOF1

Experimental group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 1mg/kg TOF2

Active Comparator group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 2mg/kg TOF1

Experimental group

Treatment:

Drug: Sugammadex Injection [Bridion]

Dose of 2mg/kg TOF2

Active Comparator group

Treatment:

Drug: Sugammadex Injection [Bridion]