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

Phase 4

• Conditions: Pharmacokinetics
• Interventions: Drug: Sugammadex

• Registration Number: NCT05187455
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

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.

Study Timeline

• Study First Submitted: 2021-12-03
• Study Start: 2022-01-05
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal transplantation(S group)	Sugammadex	n=17,CLCR≤30ml/min
the control group	Sugammadex	n=17, CLCR≥80ml/min

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of Sugammadex	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	venous blood samples were obtained

Secondary Outcome Measures

Name	Time	Method
Adverse Event	Up to 2 days	Percentage of Participants With ≥1 Adverse Event
Recovery Time and TOF ratio	up to 10 minutes from start of sugammadex	Time from start of administration of sugammadex to recovery of the T4/T1 Ratio to 0.7 、0.8、0.9

Trial Locations

Locations (1)

Guangdong Hospital of Traditional Chinese Medicine; 🇨🇳 Guanzhou, Guangdong, China