Investigation of Sugammadex in Outpatient Urological Procedures

PHASE4CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 18, 2017

Primary Completion Date

September 1, 2018

Study Completion Date

November 24, 2019

Conditions
Malignant Neoplasms of Urinary TractBladder Cancer
Interventions
DRUG

Rocuronium

Experimental: Sugammadex Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.

DRUG

Sugammadex

Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.

DRUG

Neostigmine

70 mcg/kg by vein to reverse the muscle relaxation.

DRUG

Glycopyrrolate

14 mcg/kg by vein to reverse the muscle relaxation.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT03138967 - Investigation of Sugammadex in Outpatient Urological Procedures | Biotech Hunter | Biotech Hunter