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NCT Number: NCT03904550

Neuromuscular Blockade in Patients With Severe Renal Impairment

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years old
  • Severe renal impairment (CrCl < 30 mL/min)
  • Undergoing non-emergent surgery that requires neuromuscular blockade
  • Planned extubation in the operating room immediately after surgery
  • American Society of Anesthesiologists (ASA) physical status classification 3 to 4
  • Willing and able to consent in English or Spanish
  • No personal history of neuromuscular disease

Exclusion criteria

  • Age less than 18 or older than 80
  • Patient does not speak English or Spanish
  • Planned postoperative intubation/ventilation
  • Allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium
  • Family or personal history of malignant hyperthermia
  • Patient refusal
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • Pre-existing muscle weakness of any etiology
  • Patients on toremifene (a selective estrogen receptor modulator)
  • Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery

Treatment and study plan

Cisatracurium + Neostigmine

Drug

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

Rocuronium + Sugammadex

Drug

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

Primary outcomes

  1. Time Until Complete Reversal of Neuromuscular Blockade

    Time frame: In the operating room, the amount of time after administration of the reversal syringe to reach recovery of neuromuscular function (TOFR ≥ 90%) assessed up to 30 minutes.

    Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 5, 2019
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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