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

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Unknown; Phase 4

Conditions: Pharmacokinetics

Treatments: Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT05187455

Renal Transplantation

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Renal transplantation(S group)

Experimental group

Description:

n=17,CLCR≤30ml/min

Treatment:

Drug: Sugammadex

the control group

Experimental group

Description:

n=17, CLCR≥80ml/min

Treatment:

Drug: Sugammadex