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The Eleveld Propofol Target-controlled Infusion Model of the Syringe Pump: A Multi-center Non-inferiority Clinical Trial

The Eleveld Propofol Target-controlled Infusion Model of the Syringe Pump: A Multi-center Non-inferiority Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079239
Enrollment
Unknown
Registered
2023-12-28
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects are surgical patients undergoing general anesthesia with propofol

Interventions

Eleveld Group:Targeted infusion using the Eleveld model

Sponsors

Jingzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 88 Years

Inclusion criteria

Inclusion criteria: 1) Agreed to participate in this trial and informed consent was signed by the subject or his/her legal representative; 2) Adult and pediatric patients with balanced gender distribution; 3) Patients who were anesthetized with propofol and operated for 1h to 5h; 4) Patients requiring intraoperative arterial cannulation; 5) ASA grade I - III;

Exclusion criteria

Exclusion criteria: 1) Those who have been taking alcohol or antidepressants or anxiolytics for a long time; 2) Those who are allergic to propofol or fat emulsion; 3) Patients undergoing emergency surgery; 4) Pregnant women and those who are breastfeeding; 5) Liver and kidney insufficiency; 6) Those who are less than 3 months old or more than 88 years old; 7) Patients with intraoperative bleeding greater than 400 ml and those with abnormal preoperative temperature; 8) Other conditions deemed unsuitable by the investigators;

Design outcomes

Primary

MeasureTime frame
Cp (plasma drug concentration);

Secondary

MeasureTime frame
Bispectral Index (BIS);Percentage of time that BIS is maintained at the desired value;

Countries

China

Contacts

Public ContactLishen Wang

Jingzhou Central Hospital

815606941@qq.com+86 181 0716 8482

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026