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

Sponsor

Guangzhou General Hospital of Guangzhou Military Command (Other)

Overall Status

Recruiting

CT.gov ID

NCT05187455

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine (Other)

Enrollment

Location

Arms

10.8

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: Sugammadex	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal transplantation(S group) n=17,CLCR≤30ml/min	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). Other Names: Org 25969 Bridion
Experimental: the control group n=17, CLCR≥80ml/min	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). Other Names: Org 25969 Bridion

Arm

Intervention/Treatment

Experimental: Renal transplantation(S group)

n=17,CLCR≤30ml/min

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).

Other Names:

Org 25969

Bridion

Experimental: the control group

n=17, CLCR≥80ml/min

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).

Other Names:

Org 25969

Bridion

Outcome Measures

Primary Outcome Measures

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

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
Adverse Event [Up to 2 days]
Percentage of Participants With ≥1 Adverse Event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Hospital of Traditional Chinese Medicine	Guanzhou	Guangdong	China	020

Sponsors and Collaborators

Guangzhou General Hospital of Guangzhou Military Command
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command

ClinicalTrials.gov Identifier:

NCT05187455

Other Study ID Numbers:

Renal Transplantation

First Posted:

Jan 11, 2022

Last Update Posted:

Feb 10, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command

Sugammadex

renal transplantation

Study Results

No Results Posted as of Feb 10, 2022