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CONCERT-CLE closed-loop infusion system for sedation in gastroscopy: a randomized controlled trial

CONCERT-CLE closed-loop infusion system for sedation in gastroscopy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073624
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-17
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Diseases or conditions that require gastroscopy under sedation

Interventions

experimental group:CONCERT-CLE closed-loop infusion of propofol
control group:intermittent manual infusion of propofol

Sponsors

Changhai Hospital, Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Acception of gastroscopy under sedation 2: Voluntary participation and comprehension of informed consent

Exclusion criteria

Exclusion criteria: 1: American Society of Anesthesiologists (ASA) Classification >II 2: Obstruction of upper digestive tract 3: Severe liver and/or kidney dysfunction 4: Obesity (BMI=28kg/m2) and anticipated difficult airway 5: Respiratory diseases including infection of upper respiratory tract, asthma and chronic obstructive pulmonary disease 6: Arrythmia and NYHA classification >2 7: Psychiatric diseases, use of psychotropic drugs or chronic alcoholism 8: Allergy to propofol or emulsifier

Design outcomes

Primary

MeasureTime frame
pulse oxygen saturation;Non-invasive blood pressure;Heart rate;

Secondary

MeasureTime frame
Satisfaction of the operating physician;Propofol dosage;bucking;Incidence of intraoperative body movement;emergence time;cerebral state index;

Countries

China

Contacts

Public ContactWang Jiafeng

Faculty of Anesthesiology, Changhai Hospital, Naval Medical University

feng_smmu@hotmail.com+86 137 7428 6926

Outcome results

None listed

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