Neuromuscular Blockade Clinical Trial
Official title:
The Use of Sugammadex as Rescue Therapy Following Inadequate Reversal With Neostigmine
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
Status | Recruiting |
Enrollment | 36 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, and - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time taken to achieve a TOF ratio of 0.9 after administration sugammadex | The time taken to achieve a time of train (TOF) ratio of 0.9 after the use of the intervention drug versus placebo in a patient population that has already received neostigmine for NMB reversal.
Quantitative neuromuscular monitoring will be carried out using electromyography, which measures the TOF ratio every 20 seconds. The TOF count (between 0 to 4) and the TOF ratio (0 to 1) would be measured and recorded at baseline and after administration of the study drug. If the TOF ratio remains < 0.9 after this, or if the patient exhibits any symptoms or signs of residual NMB blockade, a further 2 mg/kg dose of sugammadex would be given until the patient achieves a TOF ratio of 0.9. |
10 minutes post administration of study drug | |
Secondary | The percentage of patients who achieve a TOF ratio of 0.9 | The percentage of patients who achieve a TOF ratio of 0.9 will be measured within 1 minute, 2 minutes, 5 minutes, and 10 minutes after the administration of the study drug, sugammadex. | 1 minute, 2 minutes and 10 minutes post administration of study drug |
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