Minimal Optimal Dose of Sugammadex in Elective Surgery

Study Overview
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Brief Summary
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Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex

Detailed Description
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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

Official Title
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Minimal Optimal Dose of Sugammadex in Elective Surgery

Conditions
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Time of a TOF Ratio >0,9

Intervention / Treatment
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* Drug: Sugammadex Injection [Bridion]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel, Double blind Monocentric Prospective Vs placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dose of 0mg/kg TOF1<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Placebo Comparator: Dose of 0mg/kg TOF2<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Experimental: Dose of 0 ,5mg/kg TOF1<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Active Comparator: Dose of 0,5mg/kg TOF2<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Experimental: Dose of 1mg/kg TOF1<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Active Comparator: Dose of 1mg/kg TOF2<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Experimental: Dose of 2mg/kg TOF1<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|
| Active Comparator: Dose of 2mg/kg TOF2<br> | Drug: Sugammadex Injection [Bridion]<br>* Injection of 10mL of translucide solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the recovery time of the ratio 0.9. | Evaluate the recovery time of the ratio 0.9. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of appearance of 4 responses to the TOF | Time of appearance of 4 responses to the TOF | 1 hour | 
| Evaluate the four-to-four ratio <0.7 after total recovery. | Evaluate the four-to-four ratio <0.7 after total recovery. | 1 hour | 
| Watch time at the recovery room. | Watch time at the recovery room. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bridion, Sugammadex, TOF