The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

Not yet recruiting

• Conditions: BIS

• Registration Number: NCT06561633
• Lead Sponsor: Jun Zhang

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.

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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BIS value	5 minutes	BIS value at 5th min after sugammadex administration

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China