The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
- Registration Number
- NCT04944303
- Lead Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- age between 25 and 62 years
- body mass index （BMI）of 18.5-24.9kg/m2
- American Society of Anesthesiologists (ASA) score from I to III.
- history of allergy to narcotic drugs and other drugs
- cardiopulmonary insufficiency
- congestive heart failure
- neuromuscular disease，such as myasthenia gravis
- severe liver dysfunction
- hyperkalemia
- history of malignant hyperfever .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugammadex Normal saline 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 Normal saline the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected . Sugammadex Sugammadex 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 Sugammadex the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected .
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (2)
The Second Affiliated Hospital,Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China