Safty and Effectiveness Study for Patient Maintain Sedation Pump Using Propofol Sedation Maintained and Sssisted by Patient Reaction Time

Safty and Effectiveness Study for Patient Maintain Sedation Pump Using Propofol Sedation Maintained and Assisted by Patient Reaction Time

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042276

Enrollment

Unknown

Registered

2021-01-17

Start date

2021-02-01

Completion date

Unknown

Last updated

2021-04-19

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

Conditions

Procedural sedation

Interventions

control group:The sedation practiced by anesthisiologist

experimental group:Patient maintained sedation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. ASA I, II or III (healthy or mild to moderate, controlled systemic illness), undergoing planned (elective) Procedural sedation; 2. Aged 18 – 75 years, male and female. 3. Obtained informed consent

Exclusion criteria

Exclusion criteria: 1. Contraindication to propofol or lidocaine; 2. History of epilepsy; 3. Regular sedative medication; 4. History of illicit substance abuse; 5. Major psychiatric illness; 6. Pregnancy or breastfeeding; 7. Disorientation; 8. Unable to use necessary apparatussuch as Parkinson; 9. Intelligence deficiency; 10. Vulnerable groups without capacity; 11. Procedure-specific contraindication (i.e. emergency); 12. Other situations excluded by researchers.

Design outcomes

Primary

Measure	Time frame
Maximal change from baseline in oxygen saturation (SpO2);Incidence of loss of verbal response (PMS-PRT group);Effect site concentrations of propofol;Requirement for supplementary oxygen (if SpO2 < 93%);Minimum Sedation Score obtained (PMS-PRT group);Requirement for airway support;Operator assessment (ease of procedure, completion rate);Patient satisfaction in a Visual Analogue Scale (Questionnaire);Body movement;Recovery time;Consumption of propofol;	—

Measure

Time frame

Maximal change from baseline in oxygen saturation (SpO2);Incidence of loss of verbal response (PMS-PRT group);Effect site concentrations of propofol;Requirement for supplementary oxygen (if SpO2 < 93%);Minimum Sedation Score obtained (PMS-PRT group);Requirement for airway support;Operator assessment (ease of procedure, completion rate);Patient satisfaction in a Visual Analogue Scale (Questionnaire);Body movement;Recovery time;Consumption of propofol;

—

Countries

China

Contacts

Public ContactXu Xuebing

The University of Hong Kong-Shenzhen Hospital

xuxb@hku-szh.org+86 13533681768

Outcome results

None listed

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