Trials
Search / Trial NCT05661409

Sugammadex as Rescue Therapy

Launched by EMORY UNIVERSITY · Dec 14, 2022

Trial Information

Current as of January 13, 2025

Completed

Keywords

Neostigmine Sugammandex

ClinConnect Summary

Neuromuscular blocking (NMB) agents are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, and may require reversal in order to prevent residual NMB. This was historically done using an anticholinesterase such as neostigmine, which has many adverse effects and may not effectively reverse a deep NMB. However, the introduction of sugammadex was instrumental in allowing the rapid return of neuromuscular function. The FDA has only approved three doses of sugammadex (2 mg/kg, 4 mg/kg and 16 mg/kg) depending on the train of four (TOF)...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients aged 18 years and above who will undergo an elective surgery in the main operating room or outpatient surgery center at Grady Memorial Hospital
  • Receive general anesthesia (standardized to sevoflurane for maintenance)
  • Receive rocuronium for NMB
  • Receive neostigmine for NMB reversal
  • Achieve a TOF count of at least 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine has been given
  • Able and willing to provide informed consent.
  • Exclusion Criteria:
  • Pregnancy and/or lactating
  • BMI ≥ 40
  • Severe renal impairment, i.e. chronic kidney disease stages IV and V as defined by GFR \< 30 ml/min/1.73 m2
  • Severe hepatic impairment, i.e. Child-Pugh score C
  • Pre-existing neuromuscular disease
  • Anticipated need for postoperative intubation, and/or known hypersensitivity reactions to rocuronium, neostigmine and/or sugammadex.
  • Adults unable to consent
  • Prisoners
  • Cognitively impaired or Individuals with Impaired Decision-Making Capacity
  • Individuals who are not able to clearly understand English

Trial Officials

Rebecca Wong, MBBS, MPH

Principal Investigator

Assistant Professor

About Emory University

Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.

Locations

Atlanta, Georgia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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