- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515694
Minimal Optimal Dose of Sugammadex in Elective Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium, 1070
- Hopital Erasme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Dose of 0mg/kg TOF1
|
Injection of 10mL of translucide solution
|
Placebo Comparator: Dose of 0mg/kg TOF2
|
Injection of 10mL of translucide solution
|
Experimental: Dose of 0 ,5mg/kg TOF1
|
Injection of 10mL of translucide solution
|
Active Comparator: Dose of 0,5mg/kg TOF2
|
Injection of 10mL of translucide solution
|
Experimental: Dose of 1mg/kg TOF1
|
Injection of 10mL of translucide solution
|
Active Comparator: Dose of 1mg/kg TOF2
|
Injection of 10mL of translucide solution
|
Experimental: Dose of 2mg/kg TOF1
|
Injection of 10mL of translucide solution
|
Active Comparator: Dose of 2mg/kg TOF2
|
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.
Time Frame: 1 hour
|
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 Frame: 1 hour
|
Time of appearance of 4 responses to the TOF
|
1 hour
|
Evaluate the four-to-four ratio <0.7 after total recovery.
Time Frame: 1 hour
|
Evaluate the four-to-four ratio <0.7 after total recovery.
|
1 hour
|
Watch time at the recovery room.
Time Frame: 4 hours
|
Watch time at the recovery room.
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy FERNANDEZ, Resident, Erasme University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BRIDION_ERASME
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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