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Minimal optimal dose of Sugammadex during ambulatory surgery in dentistry

Minimal optimal dose of Sugammadex during ambulatory surgery in dentistry - SDDS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2017-005074-19-BE
Enrollment
40
Registered
2019-03-06
Start date
2018-04-06
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Bridion Product Name: Bridion Product Code: 3400957355456 Pharmaceutical Form: Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraveno

Sponsors

Erasme Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Time of appearance of 4 responses to the TOF;Secondary Objective: * Evaluate the recovery time of the ratio 0.9. * Evaluate the four-to-four ratio <0.7 after total recovery. * Watch time at the recovery room.;Primary end point(s): 40 patients included;Timepoint(s) of evaluation of this end point: When all the patients are included

Secondary

MeasureTime frame
Secondary end point(s): date of 1er Juillet;Timepoint(s) of evaluation of this end point: every week

Countries

Belgium

Contacts

Public ContactHead of anesthetics departement

Erasme Hospital

wendy.fernandez.villarreal@erasme.ulb.ac.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 15, 2026