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Neuromuscular Blockade in Patients With Severe Renal Impairment

Primary Purpose

Neuromuscular Blockade, Renal Impairment

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisatracurium + Neostigmine
Rocuronium + Sugammadex
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Blockade

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Parkland Health & Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cisatracurium + Neostigmine

Rocuronium + Sugammadex

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time Until Complete Reversal of Neuromuscular Blockade
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2019
Last Updated
June 13, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03904550
Brief Title
Neuromuscular Blockade in Patients With Severe Renal Impairment
Official Title
Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
June 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade, Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
single site, randomized, controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisatracurium + Neostigmine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rocuronium + Sugammadex
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium + Neostigmine
Intervention Description
Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
Intervention Type
Drug
Intervention Name(s)
Rocuronium + Sugammadex
Intervention Description
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
Primary Outcome Measure Information:
Title
Time Until Complete Reversal of Neuromuscular Blockade
Description
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Moon, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health & Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Neuromuscular Blockade in Patients With Severe Renal Impairment

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