The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

NCT06561633 | Completed DMC

• 1 other identifier: BIS-Sugammadex
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BIS

Outcome Measures

Primary Outcomes (1)

• BIS value

  BIS value at 5th min after sugammadex administration

  5 minutes

Interventions

Sugammadex administration DRUG

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.

Also known as: BIS monitor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun Zhang: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Jun Zhang, Professor

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 20, 2024
• Primary Completion: September 13, 2024
• Study Completion: September 14, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)