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Evaluation of a Novel AI-Driven Closed-Loop Total Intravenous Anesthesia (TIVA) Infusion System: A Safety and Efficacy Study

Prospective, Multicenter, Randomized, Single-Blind, Parallel-Group, Non-Inferiority Clinical Trial of the Intelligent Infusion Pump System for Total Intravenous Anesthesia (TIVA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108239
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

None

Interventions

Experimental group:Induction and maintenance of anesthesia through the general anesthesia intelligent pump system
Control group:Use of the same medication, performed by an anesthesiologist with extensive TIVA experience (definition: deputy chief physician and above, or with more than ten years of clinical anesthe

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with age >=18 years old and < 65 years old, male or female; 2. Elective surgery under general anesthesia is required; 3. American Society of Anesthesiologists Patient Status Classification (ASA-PS Grade) Grade I-II; 4. Subjects are able to understand, voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of drug allergy or intolerance; 2. Long-term use of opioid analgesics or other sedative drugs; 3. Pregnant or lactating women; 4. Previous or planned neurosurgery; 5. Those who have a pacemaker placed in the body; 6. Those with a history of central nervous system diseases; 7. Those who plan to undergo hypothermia surgery; 8. Those who plan to undergo cardiovascular surgery; 9. Those who plan to receive regional nerve block and/or neuraxial block anesthesia; 10. Subjects with a body mass index 28 kg/m^2; 11. Participated in or is participating in other clinical trials in the past 30 days; 12. Subjects who are not suitable for inclusion for any other reason in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
The Percentage of Effective Anesthesia Time Duration (%);

Secondary

MeasureTime frame
The percentage of time (%) during which effective sedation was maintained ;The ratio of the time to achieve and maintain an effective antinociceptive stimulus response to the time from the start of anesthesia induction to the end of surgery (%), deviating from the number of occurrences of effective antinociceptive stimulus;The ratio of effective muscle relaxation time to the time from the start of anesthesia induction to the end of surgery (%), deviating from the number of occurrences of effective muscle relaxation;Nnumber of intraoperative patient movements.;Average BIS value during the period from the induction of anesthesia to surgery completion.;The time between the start of anesthesia induction and the end of surgery was the ratio of the time between the start of anesthesia 60 to the time from the start of anesthesia induction to the end of surgery;Average propofol dose: The average dose over the period from the start of anesthesia induction to the end of surgery;Remifentanil and sufentanil mean dose: The average dose over the time from the start of anesthesia induction to the end of surgery;Mean dose of cis-atracurium: The average dose over the period from the start of induction of anesthesia to the end of surgery;Time duration from surgery completion to patient consciousness recovery.;The number of drug infusions and cumulative dosages of nicardipine, esmolol, ephedrine, and atropine from the induction of anesthesia to the completion of surgery;The number of manual adjustments in the experimental group from the induction of anesthesia to the completion of surgery;

Countries

China

Contacts

Public ContactLuo Yan

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

ly11087@rjh.com.cn+86 21 6437 0045

Outcome results

None listed

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