Street Fitness In surgical patieNts undergoing general anesthesia after reversal of neuromuscular rest blockade with sugammadeX (SFINX study) - SFINX study

Phase 1

• Conditions: Males and females in the age of 18-65 undergoing minor surgery/gynaecological procedures with a medical need for general anesthesia and neuromuscular blockade will be included in the study.

• Registration Number: EUCTR2011-000157-23-NL
• Lead Sponsor: MC St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-27
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Males and females.
- Age 18-65 years.
- Able to perform the study assessments.
- ASA classification 1 or 2.
- Medical need for general anesthesia and neuromuscular blockade.
- NMB with the standard dose of rocuronium. If the surgery lasts longer than 75 minutes the patient will be excluded.
- Minor surgical and gynecological procedures that require tracheal intubation and mechanical ventilation.
- Signed informed consent.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Contra-indications for rocuronium, sugammadex, neostigmine and/or atropine.
- Concomitant conditions or diseases that might interfere with the study assessments.
- Concomitant treatment with any experimental drug within 4 weeks before surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified