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

NCT04944303 | Completed

• 1 other identifier: Feasibility of Sugammadex
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery

Keywords

sugmmadex;; SPK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean blood pressure (MAP)

  up to 3 months

• Heart rate(HR),time（T）,hour(h)

  up to 3 months

• blood oxygen saturation (SpO2),time（T）,hour(h)

  up to 3 months

Other Outcomes (2)

• Serum creatinine (CREA,μmol/L)

  up to 3 months

• blood glucose (Glu,mmol/L)

  up to 3 months

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

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; Drug: Normal saline

Normal Saline

PLACEBO COMPARATOR

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

Drug: Sugammadex; Drug: Normal saline

Interventions

Sugammadex DRUG

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

Also known as: Bridion

Normal Saline; Sugammadex

Normal saline DRUG

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

Normal Saline; Sugammadex

Eligibility Criteria

• Age: 25 Years - 62 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (2)

The Second Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260, China

Location

MeSH Terms

Interventions

Sugammadex; Saline Solution

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shikun Qian

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This randomized, prospective, controlled, double-blind trial was conducted at the second affiliated hospital of Guangzhou Medical University,China
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 29, 2021
• Study Start: December 18, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)