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Evaluation of the effects of fospropofol disodium on cardiovascular and respiratory adverse events in middle-aged and elderly patients undergoing sedated colonoscopy: A protocol for a study based on wireless wearable (multi-parameter) real-time monitoring

Evaluation of the effects of fospropofol disodium on cardiovascular and respiratory adverse events in middle-aged and elderly patients undergoing sedated colonoscopy: A protocol for a study based on wireless wearable (multi-parameter) real-time monitoring

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117982
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

None

Interventions

Fospropofol Disodium Group (Group P):Under wireless wearable (multi-parameter) real-time monitoring, elderly patients were given fospropofol disodium 12.5 mg/kg and sufentanil 0.1 µg/kg d
Propofol Group (Group C):Under wireless wearable (multi-parameter) real-time monitoring, elderly and middle-aged patients undergoing painless colonoscopy are given propofol 2.

Sponsors

Department of Anesthesiology, Chengdu Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 50 years and above undergoing sedated colonoscopy 2.The estimated procedure duration is 20 to 30 minutes. 3.No history of cognitive impairment or able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Body mass index greater than 30 kg/m^2; 2. history of cerebral or thoracic/abdominal aortic aneurysm; 3. hypersensitivity to any of the drugs administered in the study; 4. Severe hepatic or renal impairment; 5. cardiovascular disease (history of heart failure, valvular disease, New York Heart Association Class III or IV) 6. cardiac arrhythmias (including but not limited to premature ventricular, atrial or atrial fibrillation, atrial flutter, etc.) 7. Use of antidepressants or antipsychotics; 8. mean arterial pressure (MAP) <70 mmHg before induction of anaesthesia; 9. oxygen saturation <92% without oxygen; 10. anticipated difficult airway; 11. ineligibility for inclusion as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
The composite endpoint of hypoxaemia, hypotension and bradycardia within 15 minutes of induction commencement;

Secondary

MeasureTime frame
Incidence of low heart rate;Incidence of hypoxaemia;

Countries

China

Contacts

Public ContactJiang Rongjuan

Chengdu Second People's Hospital

rongjuanjiang@163.com+86 185 0287 6250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026