Status:
UNKNOWN
Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade
Lead Sponsor:
Radboud University Medical Center
Conditions:
Anesthesia Recovery Period
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Rationale: Recovery from outpatient anesthesia includes dissipation of anesthetics agents, normalization of physiological function, observation for medical or surgical complications, treatment of imme...
Detailed Description
The number of ambulatory surgical procedures is increasing rapidly. Surgery without one or more overnight stays in hospital is appreciated by most patients and has considerable economic and efficiency...
Eligibility Criteria
Inclusion
- Males and females.
- Age 18-65 years.
- Able to perform the study assessments.
- ASA classification 1 or 2 (Appendix 1).
- 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.
- At the pre operative consult the patient will be asked if she is pregnant or if there is a possibility that she is pregnant. If yes, the patient will be excluded.
- Signed informed consent.
Exclusion
- Pregnant or lactating women.
- Contra-indications for rocuronium, sugammadex, neostigmine and/or glycopyrrolate.
- Use of toremifene, and/or fusidic acid from 24 hours before till 24 hours after surgery.
- Patients on oral hormonal contraceptives: inability/unwillingness to comply with the instructions for a missed dose according to the SPC text after surgery.
- Patients on non-oral hormonal contraceptives: inability/unwillingness to apply additional non-hormonal contraceptive methods during the 7 days after surgery.
- Concomitant conditions or diseases that might interfere with the study assessments.
- Concomitant treatment with any experimental drug within 4 weeks before surgery
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01453530
Start Date
October 1 2011
End Date
September 1 2012
Last Update
October 18 2011
Active Locations (1)
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1
UMC Sint Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB