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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03904550|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2019
Last Update Posted : January 12, 2023
|Condition or disease||Intervention/treatment||Phase|
|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:
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.
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||single site, randomized, controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blinded|
|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|
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
- 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.
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|