Clinical trial NCT04944303: The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
Official title: The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: sugmmadex;
SPK
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: The recovery time of the neuromuscular blockade in both groups
timeFrame: up to 3 months
Secondary outcomes:
measure: Mean blood pressure (MAP)
timeFrame: up to 3 months
measure: Heart rate(HR),time（T）,hour(h)
timeFrame: up to 3 months
measure: blood oxygen saturation (SpO2),time（T）,hour(h)
timeFrame: up to 3 months
Other outcomes:
measure: Serum creatinine (CREA,μmol/L)
timeFrame: up to 3 months
measure: blood glucose (Glu,mmol/L)
timeFrame: up to 3 months
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital,Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Shikun Qian
role: PRINCIPAL_INVESTIGATOR
References: