Remimazolam with esketamine for painless gastroscopy and colonoscopy in older adults

Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients

We will see if giving remimazolam with esketamine instead of remifentanil provides safe, opioid-free sedation for people 65 and older having painless gastroscopy or colonoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT07002801 on ClinicalTrials.gov

What this trial studies

This randomized interventional protocol compares remimazolam plus esketamine (opioid-free anesthesia) to remimazolam plus remifentanil (opioid-containing anesthesia) for elderly outpatients undergoing painless gastroscopy and colonoscopy. Patients are randomly assigned to the two groups and receive standard induction doses with titration during the procedure (e.g., remimazolam 0.2 mg/kg with esketamine 0.15 mg/kg or remifentanil 0.2 µg/kg). Investigators continuously record respiratory and circulatory parameters, adverse events, sedation success, recovery times, and satisfaction of patients and endoscopists. The study focuses on safety endpoints such as respiratory depression, hypotension, bradycardia, and overall success rate of sedation.

Who should consider this trial

Good fit: Adults aged 65 years or older undergoing outpatient painless gastroscopy or colonoscopy with ASA I–III who can give informed consent are ideal candidates.

Not a fit: Patients with abnormal liver or kidney function, known respiratory or endocrine disease, uncontrolled hypertension or severe cardiac failure, high BMI (>35 kg/m2), recent participation in other trials, or those on contraindicated medications may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could reduce or avoid opioid use and lower the risk of opioid-related respiratory depression while maintaining effective sedation for elderly patients.

How similar studies have performed: Remimazolam has shown promise for procedural sedation and esketamine is used for analgesia with less respiratory depression, and opioid-free anesthesia approaches have shown encouraging results although the specific remimazolam+esketamine combination remains relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients undergoing painless gastroenteroscopy in outpatient clinics;
2. aged 65 years and above;
3. American Society of Anesthesiologists (ASA) grades I - III.

Exclusion Criteria:

1. Patients with abnormal liver or kidney function;
2. known respiratory or endocrine diseases;
3. Patients with uncontrolled hypertension and NYHA classification Ⅲ-Ⅳ;
4. Taking monoamine oxidase inhibitors, sedatives, analgesics, hypnotics, antipsychotics, antiemetics or antidepressants;
5. Addiction to tobacco and alcohol;
6. Patients allergic to the investigational drug;
7. expected difficult airway;
8. Body mass index (BMI) \>35kg/m\^2;
9. Have participated in other clinical trials within the past three months;
10. Patients with psychosocial illness or cognitive dysfunction and inability to cooperate or communicate.

Where this trial is running

Harbin, Heilongjiang

• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: LIU Shujie LIU

Conditions Gastrointestinal Disease; remimazolam; esketamine; painless gastroscopy and colonoscopy; success rate of calming down