Neuromuscular Blockade in Patients With Severe Renal Impairment

Renal Impairment Clinical Trial

Official title:

Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904550
• Other study ID #: STU-2018-0411
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 1, 2023
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Cisatracurium + Neostigmine
Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
• Rocuronium + Sugammadex
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Until Complete Reversal of Neuromuscular Blockade	Measure how long it takes to return from a TOF of 2 to a TOF = 0.9.	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.