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

NCT05187455 | Unknown Phase 4

• 1 other identifier: Renal Transplantation
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Pharmacokinetics

Keywords

Sugammadex; renal transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recovery Time and TOF ratio

  up to 10 minutes from start of sugammadex

• Adverse Event

  Up to 2 days

Study Arms (2)

Renal transplantation(S group)

EXPERIMENTAL

n=17,CLCR≤30ml/min

Drug: Sugammadex

the control group

EXPERIMENTAL

n=17, CLCR≥80ml/min

Drug: Sugammadex

Interventions

Sugammadex DRUG

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

Also known as: Org 25969, Bridion

Renal transplantation(S group); the control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Guangdong Hospital of Traditional Chinese Medicine

Guanzhou, Guangdong, 020, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 21239968 BACKGROUND

• 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.

  PMID: 25829395 BACKGROUND

• 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.

  PMID: 31721151 BACKGROUND

• 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.

  PMID: 26225497 BACKGROUND

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Bo Xu

CONTACT

88653387; xubo333@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 11, 2022
• Study Start: January 5, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

CN (1)