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Comparison of the 95% effective dose of remimazolam versus propofol combined with low-dose esketamine for sedation during gastrointestinal endoscopy: a single-center randomized controlled trial

Comparison of the 95% effective dose of remimazolam versus propofol combined with low-dose esketamine for sedation during gastrointestinal endoscopy: a single-center randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085180
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-21
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Patients undergoing painless gastrointestinal endoscopy under general anesthesia

Interventions

Remimazolam group (sequential method):If a positive reaction occurs, the dose of remimazolam will be increased by 0.02mg/kg in the next patient, and in the event of a negative response, a 0.02mg/kg re
Propofol group (sequential method):If a positive reaction occurs, the dose of propofol will be increased by 0.2mg/kg in the next patient, and in the event of a negative response, a 0.2mg/kg reduction
Remimazolam group (experimental group):The ED95 dose of remimazolam was administered
Propofol group (control group):ED95 dose of propofol

Sponsors

Zhuji People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing painless gastrointestinal endoscopy under general anesthesia; 2. American anesthesiologist association (ASA) anesthesia grade I or II; 3. Aged 18-65 years; 4. body mass index (BMI) 18.5 - 29.9kg/m2.

Exclusion criteria

Exclusion criteria: 1. Severe hypertension or diabetes; 2. Coronary heart disease; 3. Central nervous system diseases; 4. Pathological obesity/obstructive sleep apnea; 5. Allergies to the study drug; 6. Take benzodiazepines intermittently or for a long time within 2 months before admission; 7. Schizophrenia and severe depression; 8. Acute upper respiratory tract infection or asthma attack; 9. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
95% effective doses of remimazolam and propofol;Changes in vital signs during the operation in the two groups;

Secondary

MeasureTime frame
The success rate of sedation and adverse reactions in the two groups;Patient satisfaction and operator satisfaction;

Countries

China

Contacts

Public ContactZhangjun Yan

Zhuji People's Hospital

949153954@qq.oom+86 152 5752 5029

Outcome results

None listed

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