Neuromuscular Blockade in Patients With Severe Renal Impairment
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ClinicalTrials.gov Identifier: NCT03904550 |
Recruitment Status :
Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : January 12, 2023
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Condition or disease | Intervention/treatment | Phase |
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Neuromuscular Blockade Renal Impairment | Drug: Cisatracurium + Neostigmine Drug: Rocuronium + Sugammadex | Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 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 |
Actual Primary Completion Date : | August 11, 2022 |
Estimated Study Completion Date : | June 29, 2023 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: Rocuronium + Sugammadex
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex |
- 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Texas | |
Parkland Health & Hospital System | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Tiffany Moon, MD | University of Texas Southwestern Medical Center |
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: | January 12, 2023 |
Last Verified: | January 2023 |
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 |
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 |