MedTrace Logo

Neuromuscular Blockade in Patients With Severe Renal Impairment

NCT03904550 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-11-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Neuromuscular Blockade
  • Renal Impairment

Interventions

DRUG

Cisatracurium + Neostigmine

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

DRUG

Rocuronium + Sugammadex

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Tiffany Moon, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2022-08-11
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904550 on ClinicalTrials.gov