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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-04-21

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.

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

This randomized, prospective, controlled, double-blind trial was conducted at the second affiliated hospital of Guangzhou Medical University,China

Study Groups

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Sugammadex

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

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

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

Normal saline

Intervention Type DRUG

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

Normal Saline

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

Group Type PLACEBO_COMPARATOR

Sugammadex

Intervention Type DRUG

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

Normal saline

Intervention Type DRUG

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

Interventions

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Sugammadex

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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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 .

Minimum Eligible Age

25 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No