Efficacy and safety of Esketamine for painless gastrointestinal endoscopy in elderly patients under continuous noninvasive hemodynamic monitoring: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600127852

Enrollment

Unknown

Registered

2026-07-08

Start date

2026-07-17

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

None listed

Interventions

Control group:Induction: IV Sufentanil 0.1 µg/kg, then 30s later slow IV Ciprofol 0.3 mg/kg for sedation

start endoscopy when CSI < 60. Maintenance: supplemental Ciprofol 0.1–0.2 mg/kg as needed based on CSI and vitals to maintain CSI 40–60.

experimental group:Induction: IV Esketamine 0.25 mg/kg for analgesia, followed 30s later by slow IV of Ciprofol 0.3 mg/kg for sedation

endoscopy starts when CSI <60. Maintenance: supplemental Ciprofol 0.1–0.2 mg/kg as needed based on CSI and vitals to maintain CSI 40–60.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for painless gastrointestinal endoscopy; 2. Aged >= 65 years; 3. Any gender; 4. Body mass index (BMI) between 18 and 28 kg/m²; 5. The American Society of Anesthesiologists (ASA) as class II to III.

Exclusion criteria

Exclusion criteria: 1. History of allergy to any drug used in this study; 2. Patients with psychiatric disorders; 3. History of chronic use or abuse of anesthetic, sedative, or analgesic medications; 4. Severe dysfunction of major organs; 5. Any other condition deemed by the investigators as inappropriate for participation in this trial.

Design outcomes

Primary

Measure	Time frame
incidence of hypotension;	—

Secondary

Measure	Time frame
Stroke volume (SV);Resting Visual Analogue Scale pain score during the recovery period;Respiratory rate (RR);Cardiac output(CO);Incidence of hypertension;Pulse oxygen saturation(SpO2);Mean arterial pressure(MAP);Postoperative nausea and vomiting and dizziness;Satisfaction with anesthesia of both patients and endoscopists;Time-related parameters;Heart rate (HR);Coughing, hiccups, body movement, and confusion;Injection pain;Systemic vascular resistance(SVR);Sinus bradycardia;Respiratory depression;	—

Measure

Time frame

Stroke volume (SV);Resting Visual Analogue Scale pain score during the recovery period;Respiratory rate (RR);Cardiac output(CO);Incidence of hypertension;Pulse oxygen saturation(SpO2);Mean arterial pressure(MAP);Postoperative nausea and vomiting and dizziness;Satisfaction with anesthesia of both patients and endoscopists;Time-related parameters;Heart rate (HR);Coughing, hiccups, body movement, and confusion;Injection pain;Systemic vascular resistance(SVR);Sinus bradycardia;Respiratory depression;

—

Countries

China

Contacts

Public ContactJing Wang

Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian)

Wjanesthesiologist@163.com+86 595 85658911

Outcome results