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Sugammadex for Neuromuscular Blockade

Phase 4
Recruiting
Led By Rebecca Wong, M.B.B.S
Research Sponsored by Emory University
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 1 minute, 2 minutes and 10 minutes post administration of study drug
Awards & highlights

Study Summary

This trial is studying how to best reverse muscle paralysis caused by anesthesia drugs. Patients who don't fully recover will get sugammadex to help.

Who is the study for?
This trial is for adults over 18 who need elective surgery at Grady Memorial Hospital, will receive general anesthesia and a muscle relaxant called rocuronium, and have partially responded to neostigmine as a reversal agent. Excluded are pregnant or breastfeeding individuals, those with severe kidney or liver issues, high BMI (≥40), cognitive impairments, neuromuscular diseases, anticipated post-op intubation needs, or allergies to the drugs involved.Check my eligibility
What is being tested?
The study tests five different doses of sugammadex as rescue therapy after inadequate reversal of muscle relaxation from neostigmine. It's a double-blind trial where patients randomly get either sugammadex or placebo without knowing which one they're receiving.See study design
What are the potential side effects?
Sugammadex may cause side effects like allergic reactions, changes in heart rate or blood pressure, headache, nausea and possible complications related to rapid return of muscle strength.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute, 2 minutes and 10 minutes post administration of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 minute, 2 minutes and 10 minutes post administration of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The time taken to achieve a TOF ratio of 0.9 after administration sugammadex
Secondary outcome measures
The percentage of patients who achieve a TOF ratio of 0.9

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sugammadex 1 mg/kgExperimental Treatment1 Intervention
The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.
Group II: Sugammadex 0.5 mg/kgExperimental Treatment1 Intervention
The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.
Group III: Sugammadex 0.25 mg/kgExperimental Treatment1 Intervention
The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.
Group IV: Sugammadex 0.125 mg/kgExperimental Treatment1 Intervention
The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.
Group V: Sugammadex 2 mg/kgActive Control1 Intervention
The study team will identify patients who are scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB and neostigmine for NMB reversal. Patients will be randomized using the Emory University REDCap (Research Electronic Data Capture) software to six groups: 2 mg/kg (the lowest dose approved by the FDA), 1 mg/kg, 0.5 mg/kg, 0.25 mg/kg, 0.125 mg/kg of sugammadex and placebo. Doses would be based on actual body weight. The time taken to reach a TOF ratio of 0.9 thereafter would be measured. If the patient fails to achieve this goal by 10 minutes, sugammadex would be given in 2 mg/kg increments until the patient reaches this threshold and can be safely extubated. The TOF ratio would be measured again at 30 minutes after arrival at the PACU to exclude delayed residual NMB with the plan to give further 2 mg/kg doses of sugammadex if detected.
Group VI: PlaceboPlacebo Group1 Intervention
The inclusion of a placebo group would allow the study team to examine if patients may recover spontaneously over that time without needing any sugammadex at all, and what parameters may predict that subset of patients. It will also improve the dose response modelling, in that randomization has been weighted so that patients who are least likely to need sugammadex (i.e. if they achieved a TOF count of 4 twitches without fade) are more likely to be in the placebo group or at the lowest dose of sugammadex that is being tested.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,621 Total Patients Enrolled
Rebecca Wong, M.B.B.SPrincipal InvestigatorAssistant Professor

Media Library

Sugammadex 1 mg/kg Clinical Trial Eligibility Overview. Trial Name: NCT05661409 — Phase 4
Neuromuscular Blockade Research Study Groups: Sugammadex 1 mg/kg, Sugammadex 0.5 mg/kg, Sugammadex 0.25 mg/kg, Sugammadex 0.125 mg/kg, Placebo, Sugammadex 2 mg/kg
Neuromuscular Blockade Clinical Trial 2023: Sugammadex 1 mg/kg Highlights & Side Effects. Trial Name: NCT05661409 — Phase 4
Sugammadex 1 mg/kg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05661409 — Phase 4

Frequently Asked Questions

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

Has the Federal Drug Administration sanctioned Sugammadex 1 mg/kg for therapeutic use?

"As this medication is approved, the level of safety associated with Sugammadex 1 mg/kg was rated a 3 on our team's scale."

Answered by AI

Does this experiment currently have openings for participants?

"The clinicaltrials.gov website notes that this study, which was initially advertised on January 1st 2023 and last amended on December 14th 2022 is no longer seeking participants. However, there are presently seventeen other medical trials looking to enroll patients at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sugammadex as Rescue Therapy
Rebecca Wong 2023. "Sugammadex as Rescue Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05661409.
~7 spots leftby Jul 2024
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