This phase IV trial studies how well sugammadex works in improving recovery conditions in participants who are undergoing urological surgical procedures for urinary system cancers or diseases. Sugammadex works by reversing the effects of muscle relaxation drugs and may improve anesthesia conditions and recovery time in participants undergoing urological surgical procedures.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03138967.
PRIMARY OBJECTIVES:
I. To determine if sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9, for outpatient bladder procedures.
SECONDARY OBJECTIVES:
I. To determine if sugammadex can improve post-operative complications for outpatient bladder procedures; such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications.
II. To determine if sugammadex can improve overall recovery time, measured by time from end of surgery to train-of-four of 0.9, for outpatient bladder procedures.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (SUGAMMADEX): Participants receive sugammadex intravenously (IV) following cystoscopy procedure.
GROUP II (STANDARD CARE): Participants neostigmine and glycopyrrolate IV per standard of care following cystoscopy.
After completion of study intervention, participants are followed up 1 day post-discharge and then again at 7 days.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFarzin Goravanchi