The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex

NCT ID: NCT06561633

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-20

Study Completion Date

2024-09-14

Brief Summary

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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

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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.

Conditions

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BIS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sugammadex administration

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.

Intervention Type DRUG

Other Intervention Names

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BIS monitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Zhang

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun Zhang, Professor

Role: STUDY_CHAIR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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BIS-Sugammadex

Identifier Type: -

Identifier Source: org_study_id

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