Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuromuscular Blockade in Patients With Severe Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904550
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Renal Impairment Drug: Cisatracurium + Neostigmine Drug: Rocuronium + Sugammadex Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single site, randomized, controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Cisatracurium + Neostigmine
Patients in the rocuronium/sugammadex group will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction. Additional rocuronium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches.
 Drug: Cisatracurium + Neostigmine
Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
Active Comparator: Rocuronium + Sugammadex
Patients in the cisatracurium/neostigmine group will receive 0.2 mg/kg of cisatracurium for neuromuscular paralysis during induction. Additional cisatracurium will be given to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery until the last 30 minutes, during which the patient will be kept at 2 twitches.
 Drug: Rocuronium + Sugammadex
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time until complete reversal of neuromuscular blockade [ Time Frame: In the operating room from induction to extubation. ]
    Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904550


Contacts
Layout table for location contacts
Contact: Tiffany Moon, MD 469-419-5790 tiffany.moon@utsouthwestern.edu
Contact: Matthew Oh, BS 310-612-7741 matthew.oh@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
Parkland Health & Hospital System Recruiting
Dallas, Texas, United States, 75390
Contact: Tiffany Moon, MD    469-419-5790    Tiffany.Moon@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tiffany B Moon, ASSOC PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03904550    
Other Study ID Numbers: STU-2018-0411
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Rocuronium
Cisatracurium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents