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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Active Comparator | In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected . |
|
| Normal Saline | Placebo Comparator | the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 3 months |
| Heart rate(HR),time（T）,hour(h) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shikun Qian | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital,Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China | ||
| Second Affiliated Hospital of Guangzhou Medical University |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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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)
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This randomized, prospective, controlled, double-blind trial was conducted at the second affiliated hospital of Guangzhou Medical University,China
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|
| Normal saline | Drug | Equal doseage of normal saline was injected to reverse the NMB. |
|
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) |
| 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) | 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) |
| up to 3 months |
| Guangzhou |
| 510260 |
| China |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |