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A prospective, multicenter, randomized controlled clinical trial evaluating the efficacy and safety of self-controlled sedation syringe pumps for patient-controlled sedation in non-general anesthesia surgery.

A prospective, multicenter, randomized controlled clinical trial evaluating the efficacy and safety of self-controlled sedation syringe pumps for patient-controlled sedation in non-general anesthesia surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108266
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
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

Maintain Sedation

Interventions

control group: Targeted controlled sedation by the anesthesia investigator.
Test group:Patient Maintain Sedation

Sponsors

Shenzhen People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years old, male or female; 2. ASA grade I, II, or III (healthy or with mild to moderate controllable systemic disease), planned (elective) surgery under non-general anesthesia; 3. BMI ranges from 18.0kg/m^2<=BMI<=28.0kg/m^2; 4. Those who are expected to have surgery time greater than 1 hour; 5. Those who can fully pass the assessment after training in the use of test equipment.

Exclusion criteria

Exclusion criteria: 1. Persons with decompensation of vital organ function and uncontrollable serious psychosomatic diseases; 2. History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc.; 3. Those with a history of epilepsy; 4. Those with disorientation; 5. Parkinson's syndrome, abnormal nerve reflexes in the arm, etc., motor dysfunction that cannot control arm movements He who; 6. Missing or injured arm; 7. Those who are contraindicated to propofol 8. Preference for surgery in full consciousness; 9. Those with a history of drug abuse; 10. Those who use narcotic drugs or sedative drugs within 1 week before surgery; 11. Pregnant or lactating women; 12. Those who understand the test instruments or sedation process, such as doctors, nurses, anesthesiologists, etc., have a medical background The Scener; 13. Those who have participated in other clinical trials in the past three months; 14. Other situations that the investigator deems unsuitable for enrollment, such as inability to cooperate with follow-up.

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
sedation score;EEG bispectral index;propofol dosage;anxiety level;body movement score; surgeon satisfaction,;patient satisfaction;device performance evaluation.;

Countries

China

Contacts

Public ContactWu Chaoran

Shenzhen People's Hospital

Curtishuang@veryark.com+86 181 0028 2848

Outcome results

None listed

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