Minimal Optimal Dose of Sugammadex in Elective Surgery

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

Study Overview

• Status: Completed
• Conditions: Time of a TOF Ratio >0,9
• Intervention / Treatment: Drug: Sugammadex Injection [Bridion]

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Hôpital Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Wendy FERNANDEZ, Resident, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Sugammadex; TOF; Bridion
• Other Study ID Numbers: BRIDION_ERASME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No