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

Second Affiliated Hospital of Guangzhou Medical University52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

SugammadexDRUG

Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium

Normal salineDRUG

Equal doseage of normal saline was injected to reverse the NMB.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 62 Years

Medical Language ↔ Plain English

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 .

Locations (2)

The Second Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, China

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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