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Impact of Sedation with Ciprofol versus Propofol on the Incidence of Hypoxemia and Hypotension in Elderly Patients Undergoing Bidirectional Endoscopy: A Randomized Controlled Clinical Trial

Impact of Sedation with Ciprofol versus Propofol on the Incidence of Hypoxemia and Hypotension in Elderly Patients Undergoing Bidirectional Endoscopy: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117418
Enrollment
Unknown
Registered
2026-01-23
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Hypotension and Hypoxemia During Gastrointestinal Endoscopy

Interventions

Ciprofol Group:A loading dose of 0.3 mg/kg ciprofol was administered intravenously over a minimum period of 30 seconds.
Propofol Group:A loading dose of 1.5 mg/kg propofol was administered intravenously over a minimum period of 30 seconds.

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years; 2. Planning to undergo elective digestive endoscopy with sedation; 3. American Society of Anesthesiologists (ASA) classification I–III; 4. Pre-procedure pulse oxygen saturation (SpO2) in room air >= 93%; 5. Voluntarily participating in this study and signing the informed consent form. If the subject is unable to read or sign the informed consent due to lack of capacity, the consent process must be conducted by their guardian, who will sign the informed consent on their behalf.

Exclusion criteria

Exclusion criteria: 1. Emergency endoscopic examination; 2. Severe cardiovascular or pulmonary diseases (such as decompensated heart failure, severe chronic obstructive pulmonary disease); 3. Baseline systolic blood pressure <90 mmHg or heart rate <50 beats/min; 4. Allergies to remimazolam, propofol, or opioids; 5. Anticipated difficult airway or severe obesity; 6. Severe liver, kidney, neurological, or metabolic diseases; 7. History of alcohol or drug abuse; 8. Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterate individuals, etc.; 9. Other conditions that the investigator considers make the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
hypoxemia;hypotension;Sedation Induction Time;

Secondary

MeasureTime frame
incidence of hypoxemia alone;incidence of hypotension alone;Incidence of Airway Interventions (e.g., Jaw Thrust, Oropharyngeal/Nasopharyngeal Airway Insertion, Assisted Ventilation);Usage of Vasoactive Drugs;Endoscopist Satisfaction;Patient Satisfaction;Total Dosage of Sedative Drugs;PACU Discharge Time;Time to Full Consciousness (MOAA/S = 5);

Countries

China

Contacts

Public ContactChen Gang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@zju.edu.cn+86 137 5711 8681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026