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Pharmacodynamics of Esketamine Combined with Remimazolam for Painless Gastrointestinal Endoscopy in Elderly Patients: A Sequential Trial with a Biased Coin Design

Pharmacodynamics of Esketamine Combined with Remimazolam for Painless Gastrointestinal Endoscopy in Elderly Patients: A Sequential Trial with a Biased Coin Design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128009
Enrollment
Unknown
Registered
2026-07-13
Start date
2026-07-13
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

None

Interventions

Experimental group:Esketamine was administered in combination with remimazolam for intravenous anesthesia

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 65–80 years; 2.American Society of Anesthesiologists (ASA) physical status class II–III; 3.Body mass index (BMI) 18.5–28.0 kg/m^2; 4.Scheduled for elective sedated gastrointestinal endoscopy; 5.Able to comprehend the study protocol, voluntarily agree to participate, and provide written informed consent personally signed by the participant

Exclusion criteria

Exclusion criteria: 1.Presence of language, visual, hearing, mental, psychological, or neurological impairments that preclude effective communication, provision of informed consent, or cooperation with the endoscopic procedure; 2.Occurrence of cerebrovascular accident, myocardial infarction, or unstable angina within the past 3 months, or presence of severe cardiac, hepatic, or renal dysfunction; 3.Presence of significant high-risk factors for the airway or respiratory system, such as severe obstructive sleep apnea, a history of difficult airway, or acute or severe bronchial asthma; 4.Allergy or contraindication to remimazolam, esketamine, or propofol; 5.Use of opioids, sedative-hypnotics, or other centrally active medications that may affect sedation or respiratory assessment within the past 48 hours; 6.Chronic pain or cancer pain requiring long-term analgesic medication; 7.Participation in other drug clinical trials within the past 3 months; 8.Any other condition deemed by the investigator to be unsuitable for participation in this study;

Design outcomes

Primary

MeasureTime frame
Patient Responses During Gastroscopy;

Secondary

MeasureTime frame
Heart rate;Esketamine dose;Total dose of remimazolam;Recovery Time;Discharge Time;Mean Arterial Pressure;Adverse Events;Pulse oximetry saturation;Examination Duration;

Countries

China

Contacts

Public ContactChun Yang

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

chunyang@njmu.edu.cn+86 25 6830 6360

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026