The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery

Conditions
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Surgery

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 .

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugammadex<br>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<br>* Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium<br>* Other names: Bridion;Drug: Normal saline<br>* Equal doseage of normal saline was injected to reverse the NMB.<br>|
| Placebo Comparator: Normal Saline<br>the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected . | Drug: Sugammadex<br>* Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium<br>* Other names: Bridion;Drug: Normal saline<br>* Equal doseage of normal saline was injected to reverse the NMB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugmmadex;, SPK