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Cisatracurium + Neostigmine for Kidney Failure

Phase 2
Waitlist Available
Led By Tiffany Moon, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial is testing two different drugs to see which is better at reversing the effects of anesthesia in people with severe kidney impairment.

Eligible Conditions
  • Kidney Failure
  • Neuromuscular Blockade

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time Until Complete Reversal of Neuromuscular Blockade

Trial Design

2Treatment groups
Active Control
Group I: Cisatracurium + NeostigmineActive Control1 Intervention
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.
Group II: Rocuronium + SugammadexActive Control1 Intervention
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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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,726 Total Patients Enrolled
2 Trials studying Kidney Failure
1,526 Patients Enrolled for Kidney Failure
Tiffany Moon, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
8 Previous Clinical Trials
4,989 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being signed up for this clinical trial?

"This study has already completed recruitment and is no longer admitting patients. The trial was first posted on December 10th, 2019 and was most recently edited on August 29th, 2022. However, there are many other ongoing clinical trials that may be of interest. For instance, there are 187 kidney failure studies and 36 Cisatracurium + Neostigmine trials currently recruiting patients."

Answered by AI

What are the common indications for Cisatracurium + Neostigmine?

"Cisatracurium + Neostigmine is most often used to make tracheal intubation easier. This medication can also be given to patients post-operatively for intestinal atony, denture retention, or ogilvie's syndrome."

Answered by AI

Are there any unfilled slots in this research project?

"This trial is not currently looking for patients. The study was posted on December 10th, 2019 and the most recent edit was on August 29th, 2022. However, if you are still interested in participating in a clinical trial, there are 187 studies for kidney failure and 36 Cisatracurium + Neostigmine trials that are admitting patients."

Answered by AI

Is the use of Cisatracurium + Neostigmine accepted by the FDA?

"Cisatracurium + Neostigmine received a 2 because, while there is evidence of safety, Phase 2 trials have not yet gathered data to confirm efficacy."

Answered by AI

Does this study have any barriers to entry for willing participants?

"The prerequisites for enrolment in this clinical study are kidney failure and being between 18-80 years old. Only 48 patients will be accepted in total."

Answered by AI

To your knowledge, does a study like this one exist?

"Cisatracurium + Neostigmine has been researched since 2009. The initial clinical trial occurred in 2009 and was sponsored by Medtronic - MITG. Following the first trial in 2009, which involved 80, Cisatracurium + Neostigmine received its N/A drug approval. Today there are 36 active trials for Cisatracurium + Neostigmine across 46 cities and 22 countries."

Answered by AI

If a patient is over the age of 40, can they still participate in this clinical trial?

"The age limit for this trial is 18-80 years old. If an applicant does not meet this criterion, they can look into the 15 other clinical trials for people under 18 or the 209 trials designed for patients 65 and older."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neuromuscular Blockade in Patients With Severe Renal Impairment
Tiffany B Moon 2019. "Neuromuscular Blockade in Patients With Severe Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904550.
~9 spots leftby Apr 2025
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