Surgery
Conditions
Keywords
sugmmadex;, SPK
Brief summary
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.
Detailed description
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.
Interventions
DRUGSugammadex
Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium
DRUGNormal saline
Equal doseage of normal saline was injected to reverse the NMB.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This randomized, prospective, controlled, double-blind trial was conducted at the second affiliated hospital of Guangzhou Medical University,China
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
25 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
1. age between 25 and 62 years 2. body mass index （BMI）of 18.5-24.9kg/m2 3. American Society of Anesthesiologists (ASA) score from I to III.
Exclusion criteria
1. history of allergy to narcotic drugs and other drugs 2. cardiopulmonary insufficiency 3. congestive heart failure 4. neuromuscular disease，such as myasthenia gravis 5. severe liver dysfunction 6. hyperkalemia 7. history of malignant hyperfever .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recovery time of the neuromuscular blockade in both groups | up to 3 months | Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean blood pressure (MAP) | up to 3 months | 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) |
| Heart rate(HR),time（T）,hour(h) | up to 3 months | 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) |
| blood oxygen saturation (SpO2),time（T）,hour(h) | up to 3 months | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine (CREA,μmol/L) | up to 3 months | 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) |
| blood glucose (Glu,mmol/L) | up to 3 months | 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) |
Countries
China
Outcome results
None listed