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

Second Affiliated Hospital of Guangzhou Medical University

Status: Completed

Conditions: Surgery

Treatments: Drug: Sugammadex; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04944303

Feasibility of Sugammadex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 25 to 62 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

Sugammadex

Active Comparator group

Description:

In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected .

Treatment:

Drug: Sugammadex

Drug: Normal saline

Normal Saline

Placebo Comparator group

Description:

the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected .

Treatment:

Drug: Sugammadex

Drug: Normal saline