Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187455
• Other study ID #: Renal Transplantation
• Status: Recruiting
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2022
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Bo Xu
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Sugammadex
Each patient received a single dose administration of sugammadex 2mg/kg at reappearance of the second twitch of the train-of-four (TOF).

Locations

Country	Name	City	State
China	Guangdong Hospital of Traditional Chinese Medicine	Guanzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command	Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Sugammadex	venous blood samples were obtained	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	Recovery Time and TOF ratio	Time from start of administration of sugammadex to recovery of the T4/T1 Ratio to 0.7 ?0.8?0.9	up to 10 minutes from start of sugammadex
Secondary	Adverse Event	Percentage of Participants With =1 Adverse Event	Up to 2 days