Clinical trial NCT05187455: Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation
Official title: Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pharmacokinetics
Keywords: Sugammadex
renal transplantation
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2022-01-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of rocuronium-induced moderate neuromuscular blockade in patients during renal transplantation

Detailed description: 34 patients undergoing renal transplantation or elective surgery are divided into 2 groups, including transplantation group (S group,n=17) and control group (C group, n=17). Patients age 18 to 65 and ASA glass I-III

Anaesthesia is induced and maintained with i.v. propofol and an opioid. Neuromuscular monitoring was performed at the adductor pollicis muscle with acceleromyography (TOF-Watch®SX, Organon Ireland Ltd, a division of Merck and Co., Dublin, Ireland). After calibration of the TOF-Watch®SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB Patients receive sugammadex 2 mg/kg i.v. for reversal when surgery finish and T2 reappears.

Venous blood samples of C group(within 12hours) and S group(within 48hours) are obtained before administration of Sug and at specified time points after administration of Sug to determine plasma concentration using HPLC-MS. Time from start of administration of Sug to recovery of TOF ratio to 0.7, 0.8, 0.9 and other clinical indicators are also recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min),or patients undergo elective surgery in supine position(CLCR≥80ml/min)
2. Patients age 18 to 65
3. ASA glass I-III

Exclusion Criteria:

1. patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2
2. Pregnant or lactating women
3. neuromuscular disorders, hepatic dysfunction, cardiac disease, a history of malignant hyperthermia, or
4. allergic history during general anesthesia
5. patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium,fusidic acid,toremifene and/or flucloxacillin

Primary outcomes:
measure: Plasma Concentration of Sugammadex
timeFrame: Samples were obtained pre-dose and at specified post-dose time points. C group: up to 12 hours post-dose, S group: up to 48 hours post-dose
Secondary outcomes:
measure: Recovery Time and TOF ratio
timeFrame: up to 10 minutes from start of sugammadex
measure: Adverse Event
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
References:
citation: McDonagh DL, Benedict PE, Kovac AL, Drover DR, Brister NW, Morte JB, Monk TG. Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients. Anesthesiology. 2011 Feb;114(2):318-29. doi: 10.1097/ALN.0b013e3182065c36.
citation: Panhuizen IF, Gold SJ, Buerkle C, Snoeck MM, Harper NJ, Kaspers MJ, van den Heuvel MW, Hollmann MW. Efficacy, safety and pharmacokinetics of sugammadex 4 mg kg-1 for reversal of deep neuromuscular blockade in patients with severe renal impairment. Br J Anaesth. 2015 May;114(5):777-84. doi: 10.1093/bja/aet586. Epub 2015 Mar 31.
citation: Adams DR, Tollinche LE, Yeoh CB, Artman J, Mehta M, Phillips D, Fischer GW, Quinlan JJ, Sakai T. Short-term safety and effectiveness of sugammadex for surgical patients with end-stage renal disease: a two-centre retrospective study. Anaesthesia. 2020 Mar;75(3):348-352. doi: 10.1111/anae.14914. Epub 2019 Nov 12.
citation: de Souza CM, Tardelli MA, Tedesco H, Garcia NN, Caparros MP, Alvarez-Gomez JA, de Oliveira Junior IS. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial. Eur J Anaesthesiol. 2015 Oct;32(10):681-6. doi: 10.1097/EJA.0000000000000312.