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Low-dose esketamine as an adjuvant to propofol sedation for same-visit bidirectional endoscopy: A prospective, multicenter, randomized, controlled trial

Low-dose esketamine as an adjuvant to propofol sedation for same-visit bidirectional endoscopy: A prospective, multicenter, randomized, controlled trial - The EPSE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055938
Enrollment
Unknown
Registered
2022-01-26
Start date
2022-02-08
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Sedation for gastrointestinal endoscopy

Interventions

Normal saline group:Normal saline
Esketamine group:Esketamine 0.15mg/kg

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 70 years; 2. ASA physical status I to II; 3. BMI 18-30 kg/m^2; 4. Scheduled for same-visit bidirectional endoscopy under sedation.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular or pulmonary diseases; 2. Renal or liver dysfunction; 3. Neurocognitive or psychiatric disorders; 4. Epilepsy; 5. Hypersensitivity to study medications; 6. Drug or alcohol misuse; 7. Refusal to participate.

Design outcomes

Primary

MeasureTime frame
a composite outcome of desaturation and hypotension;—

Secondary

MeasureTime frame
desaturation;hypotension;total dose of propofol;pain scores;fatigue scores;dizziness or headache;hallucination or nightmare;nausea or vomiting;endoscopist satisfaction;patient satisfaction;—

Countries

China

Contacts

Public ContactJi Fuhai

The First Affiliated Hospital of Soochow University

jifuhai@hotmail.com+86 136 5620 7331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026