Neuromuscular BlockadePhase 2NCT03904550
Neuromuscular Blockade in Patients With Severe Renal Impairment
A Phase 2 study testing Cisatracurium + Neostigmine and Rocuronium + Sugammadex in people with Neuromuscular Blockade and Renal Impairment, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade, Renal Impairment
- What is being tested?
- Cisatracurium + Neostigmine and Rocuronium + Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health & Hospital System
Dallas, Texas, 75390
About this study
Official title: Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
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.
Read the 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.
- Conditions
- Neuromuscular Blockade, Renal Impairment
- Being tested
- Cisatracurium + Neostigmine, Rocuronium + Sugammadex
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisatracurium + NeostigmineDrug
Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
Rocuronium + SugammadexDrug
Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Cisatracurium + Neostigmine | Active comparator | 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. Receives: Drug: Cisatracurium + Neostigmine |
| Rocuronium + Sugammadex | Active comparator | 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. Receives: Drug: Rocuronium + Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until Complete Reversal of Neuromuscular Blockade
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start10 Dec 2019
- Primary completion11 Aug 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single site, randomized, controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany B Moon, University of Texas Southwestern Medical Center
- Investigators
- Tiffany Moon, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904550
- Sponsor's protocol ID
- STU-2018-0411
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2019
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT03904550
- Acronym / sponsor ID
- STU-2018-0411
- Conditions
- Neuromuscular Blockade, Renal Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single site, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Cisatracurium + Neostigmine | Active comparator | Drug: Cisatracurium + NeostigminePatients 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. |
| Rocuronium + Sugammadex | Active comparator | Drug: Rocuronium + SugammadexPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisatracurium + NeostigmineMaintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate | Drug | Cisatracurium + Neostigmine |
| Rocuronium + SugammadexMaintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex | Drug | Rocuronium + Sugammadex |
Primary outcome
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.
Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Moon, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisatracurium + Neostigmine and Rocuronium + Sugammadex in people with Neuromuscular Blockade and Renal Impairment, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.