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Median effective dose of remazolam besilate in combination with different doses of esketamine for painless gastroscopy:A randomized controlled, double-blind, prospective study

Median effective dose of remazolam besilate in combination with different doses of esketamine for painless gastroscopy:A randomized controlled, double-blind, prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068488
Enrollment
Unknown
Registered
2023-02-21
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

gastrointestinal endoscopy

Interventions

Esketamine 0mg group:Induction of anesthesia using 0mg esketamine combined with remazolam besylate
Esketamine 0.2mg/kg group:Induction of anesthesia using 0.2mg/kg esketamine combined with remazolam besylate
Esketamine 0.4mg/kg group:Induction of anesthesia using 0.4mg/kg esketamine combined with remazolam besylate
Esketamine 0.6mg/kg group :Induction of anesthesia using 0.6mg/kg esketamine combined with remazolam besylate

Sponsors

Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old; 2. Body mass index 19-28kg/m^2; 3. ASA I-III grade; 4. All selected participants agree to participate in this research and sign.

Exclusion criteria

Exclusion criteria: 1. Acute heart failure, unstable angina, myocardial infarction within 6 months, resting electrocardiogram (ECG) heart rate = 180 mmHg or diastolic blood pressure >= 90 mmHg 3. Acute respiratory infection, acute exacerbation of COPD, poorly controlled asthma 4. End-stage renal failure and hepatic decompensation 5. Mental disorders include: schizophrenia, mania, bipolar disorder, or cognitive dysfunction 6. Those who are allergic to benzodiazepines or ketamine 7. Those who have taken benzodiazepines in the past 3 months or have a history of general anesthesia surgery 8. Complicated endoscopic operations, such as gastric polypectomy, etc. 9. Pregnant and lactating women 10. Unable to cooperate with psychosocial problems and other reasons.

Design outcomes

Primary

MeasureTime frame
median effective dose;

Secondary

MeasureTime frame
anesthesia induction time;operation time;Anesthesia recovery time;Anesthetic dosage;Endoscopy physician satisfaction;patient satisfaction;adverse reactions;

Countries

China

Contacts

Public ContactLi Linji

Department of Anesthesiology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College

llj-stwphen@163.com+86 152 2815 2382

Outcome results

None listed

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