Ciprofol vs. propofol sedation combined with esketamine or placebo for same-visit bidirectional endoscopy: a randomized, double-blind, controlled trial with factorial design

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052523

Enrollment

Unknown

Registered

2021-10-30

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-10-17

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

Group 1:ciprofol + esketamine

Group 2:propofol + esketamine

Group 3:ciprofol + placebo

Group 4:propofol + placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >= 18 years; 2. ASA physical status I to III; 3. Scheduled for same-visit bidirectional endoscopy under sedation.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular or pulmonary diseases, renal or liver dysfunction, neurocognitive or psychiatric disorders, epilepsy; 2. Hypersensitivity to study medications; 3. Drug or alcohol misuse; 4. Refusal to participate.

Design outcomes

Primary

Measure	Time frame
a composite outcome of desaturation and hypotension;	—

Secondary

Measure	Time frame
desaturation;severe desaturation;hypotension;severe hypotension;bradycardia;nausea and vomiting;dizzness and headache;dose of sedatives;Time to emergence;injection pain;VAS pain scores;VAS fatigue scores;hallucination or nightmare;endoscopist satisfaction;patient satisfaction;	—

Countries

China

Contacts

Public ContactPeng Ke

The First Affiliated Hospital of Soochow University

pengke0422@163.com+86 15962155989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026