Clinical trial NCT03515694: Minimal Optimal Dose of Sugammadex in Elective Surgery
Official title: Minimal Optimal Dose of Sugammadex in Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Time of a TOF Ratio >0,9
Keywords: Bridion
Sugammadex
TOF
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, Double blind Monocentric Prospective Vs placebo
Primary purpose: TREATMENT

Brief summary: Time of appearance of TOF Ratio \>0,9 with different doses of Sugammadex

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the recovery time of the ratio 0.9.
timeFrame: 1 hour
Secondary outcomes:
measure: Time of appearance of 4 responses to the TOF
timeFrame: 1 hour
measure: Evaluate the four-to-four ratio <0.7 after total recovery.
timeFrame: 1 hour
measure: Watch time at the recovery room.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hopital Erasme
Study officials:
affiliation: Erasme University Hospital
name: Wendy FERNANDEZ, Resident
role: PRINCIPAL_INVESTIGATOR
References: