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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944303
• Other study ID #: Feasibility of Sugammadex
• Status: Completed
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 62 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Sugammadex
Sugammadex is a modified ?-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium
• Normal saline
Equal doseage of normal saline was injected to reverse the NMB.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The Second Affiliated Hospital,Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum creatinine (CREA,µmol/L)	Serum creatinine (CREA) 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)	up to 3 months
Other	blood glucose (Glu,mmol/L)	blood glucose (Glu,mmol/L) 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)	up to 3 months
Primary	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	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)	up to 3 months
Secondary	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)	up to 3 months
Secondary	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)	up to 3 months