Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neuromuscular Blockade
  • Renal Impairment
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: single site, randomized, controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: double blindedPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

This will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following: Specific Aim: To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular fu...

This will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following: Specific Aim: To determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular function (TOF ? 0.9) faster than reversal of cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients with severe renal impairment. Primary Hypothesis: Patients with severe renal impairment who are reversed with sugammadex after rocuronium will achieve a TOF ?0.9 within a time frame that is one-third of the time it takes for reversal with neostigmine after cisatracurium.

Tracking Information

NCT #
NCT03904550
Collaborators
Not Provided
Investigators
Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center