- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904550
Neuromuscular Blockade in Patients With Severe Renal Impairment
Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- Parkland Health & Hospital System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cisatracurium + Neostigmine
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.
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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 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.
|
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches.
For reversal, sugammadex
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
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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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tiffany Moon, MD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Renal Insufficiency
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Neuromuscular Agents
- Cholinesterase Inhibitors
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Parasympathomimetics
- Rocuronium
- Cisatracurium
- Neostigmine
Other Study ID Numbers
- STU-2018-0411
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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