The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex Administration During Steady-state Anesthesia

Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics.

Study Overview

• Status: Completed
• Conditions: BIS
• Intervention / Treatment: Drug: Sugammadex administration

Detailed Description

Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics. Patients undergoing elective surgery were included in this study. After surgery was completed while the train-of-four ratio was zero, a steady-state intravenous anesthesia was maintained to keep a BIS value within the range of 40-60 for at least 5 minutes. Patients received sugammadex 2 mg.kg-1 after completed surgery. BIS values were recorded every minute and clinical signs of awaking was also noted.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This observational cohort study was approved by the Institutional Review Board of the Fudan University Shanghai Cancer Center (No.2407-Exp042). Patients with ASA Ⅰ - Ⅱ scheduled for elective surgery who agreed to participate and who signed the informed consent were included.

Description

Inclusion Criteria:

• Patients with American Society of Anesthesiologists (ASA) physical status Ⅰ - Ⅱ scheduled for elective surgery who agreed to participate and who signed the informed consent were included. Other inclusion criteria were age between 18 and 80 years and scheduled for elective non-cardiothoracic and non-neurological cancer surgery under general anesthesia (GA)

Exclusion Criteria:

• Known hypersensitivity to sugammadex; severe renal insufficiency (creatinine clearance < 30 ml.min-1); treatment with toremifene, flucloxacillin or fusidic acid in the pre-operative or immediate postoperative period; and neuropsychiatric disorders or treatment with a psychotropic agent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS value	BIS value at 5th min after sugammadex administration	5 minutes

Collaborators and Investigators

• Sponsor: Jun Zhang
• Investigators: Study Chair: Jun Zhang, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 14, 2024

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BIS-Sugammadex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No