Clinical trial NCT03904550: Neuromuscular Blockade in Patients With Severe Renal Impairment
Official title: Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuromuscular Blockade
Renal Impairment
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single site, randomized, controlled
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time Until Complete Reversal of Neuromuscular Blockade
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Tiffany Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: