The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

NCT06561633 — Completed, 135 participants, Jun Zhang

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

RegistryNCT06561633
StatusCompleted
Study typeObservational
Enrollment135 (Actual)
SponsorJun Zhang (Other)
ConditionsBIS
InterventionsSugammadex administration (Drug)
Datesstart 2024-08-20, primary completion 2024-09-13, completion 2024-09-14, first posted 2024-08-20, last updated 2024-09-25
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for BIS All trials of Sugammadex administration

-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.

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+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.

+Arms and interventions

  • Sugammadex administration (Drug), also known as BIS monitor: 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.

+Outcome measures

Primary outcomes

  • BIS value [5 minutes]: BIS value at 5th min after sugammadex administration

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

FacilityCityCountryStatus
Fudan University Shanghai Cancer CenterShanghai, Shanghai MunicipalityChina

+Investigators