CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Cisatracurium + Neostigmine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03904550
NCT03904550Phase 2Completed

Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

University of Texas Southwestern Medical Center·interventional·Posted Apr 5, 2019·Updated Nov 8, 2023

In Brief

A Phase 2 clinical trial evaluating Cisatracurium + Neostigmine and Rocuronium + Sugammadex for Neuromuscular Blockade and Renal Impairment. Completed, enrolled 49 participants across 1 site.

Detailed Summary

This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 5, 2019
Enrollment StartDec 10, 2019
Primary CompletionAug 11, 2022
Study CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.2 years ago

Interventions

Cisatracurium + Neostigminedrug

Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate

Rocuronium + Sugammadexdrug

Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex