An interventional study of Sugammadex and Normal saline in Surgery, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Completed at 2 sites in China. Open to participants aged 25 Years to 62 Years. Per ClinicalTrials.gov, last updated 2021-06-29.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay.
A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA), blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5), and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and stay time in PACU were recorded.
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In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected .
Drug: Sugammadex · Drug: Normal saline
the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected .
Drug: Sugammadex · Drug: Normal saline
Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium
Also known as: Bridion
Equal doseage of normal saline was injected to reverse the NMB.
The recovery time of the neuromuscular blockade in both groups
Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB
Time frame: up to 3 months
Mean blood pressure (MAP)
MAP was measured at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Time frame: up to 3 months
Heart rate(HR),time（T）,hour(h)
HR was measured at at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Time frame: up to 3 months
blood oxygen saturation (SpO2),time（T）,hour(h)
SpO2 was measured at at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Time frame: up to 3 months
Serum creatinine (CREA,μmol/L)
Serum creatinine (CREA) was measured at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Time frame: up to 3 months
blood glucose (Glu,mmol/L)
blood glucose (Glu,mmol/L) was measured at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Time frame: up to 3 months
Plan to share: No
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sugammadex
Second Affiliated Hospital of Guangzhou Medical University