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NCT05661409
Sugammadex as Rescue Therapy
Conditions: Neuromuscular Blockade
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 36
Sponsor: Emory University
Location: United States
Summary
Neuromuscular blocking agents (NMBAs) are commonly used in the practice of anesthesiology for skeletal muscle relaxation to facilitate tracheal intubation, mechanical ventilation, and to provide optimal surgical conditions.
In order to prevent residual NMB, it is vital to adequately reverse any use of a non-depolarizing NMBA.
This was historically done using an anticholinesterase such as neostigmine, which would increase the concentration of acetylcholine at the neuromuscular junction leading to the return of neuromuscular transmission.
Unfortunately, there are disadvantages to the use of an anticholinesterase.
It was in this context that sugammadex was found to be a valuable addition to the anesthesiologist's armamentarium.
It is a modified γ-cyclodextrin that encapsulates the aminosteroid NMBAs rocuronium and vecuronium.This project is a double-blind randomized placebo-controlled dose-response trial that aims to determine the time taken to achieve adequate reversal comparing five doses of sugammadex as rescue therapy following inadequate reversal with neostigmine.
The study team will recruit patients aged 18 years and above from the main operating room and outpatient surgery center at Grady Memorial Hospital who are undergoing elective surgery under general anesthesia, who has received NMB, received neostigmine for NMB reversal, and achieved a TOF count ≥ 3 twitches but not a TOF ratio of 0.9 fifteen minutes after neostigmine was given.
Those with a TOF count < 3 twitches will drop out of the study as there are already specified doses of sugammadex for that level of NMB
Eligibility Criteria
Inclusion Criteria:Patients aged 18 years and above who willUndergo 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, andAble and willing to provide informed consent.Exclusion Criteria:Pregnancy and/or lactatingBMI ≥ 40,Severe renal impairment, i.e. chronic kidney disease stages IV and V as defined by GFR < 30 ml/min/1.73
m2Severe hepatic impairment, i.e.
Child-Pugh score CPre-existing neuromuscular disease,Anticipated need for postoperative intubation, and/orKnown hypersensitivity reactions to rocuronium, neostigmine and/or sugammadex.Adults unable to consentPrisonersCognitively impaired or Individuals with Impaired Decision-Making CapacityIndividuals who are not able to clearly understand English
Source: ClinicalTrials.gov (NCT05661409). StuddyBuddy aggregates publicly available trial information.