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Comparison of anesthetic effects of fospropofol disodium and propofol in elderly patients undergoing painless bronchoscopy

Comparison of anesthetic effects of fospropofol disodium and propofol in elderly patients undergoing painless bronchoscopy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128516
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Painless bronchoscopy

Interventions

Propofol group (C group):Intravenous administration of alfentanil 5 µg/kg, followed by slow intravenous injection of propofol 1.5 mg/kg (injection time within 60 s)
intraoperative additional dose of propofol 0.5 mg/kg according to patient response
if MOAA/S score >1, additional dose of propofol 1.5 mg/kg
Fospropofol disodium group (F group):Intravenous administration of alfentanil 5 µg/kg, followed by slow intravenous injection of fospropofol disodium 10 mg/kg (injection time within 60 s)
intraoperative additional dose of fospropofol disodium 2.0 mg/kg according to patient response
if MOAA/S score >1, additional dose of fospropofol disodium 2.0 mg/kg

Sponsors

The Second Hospital of Jiaxing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=65 years, any gender; 2. Planning to undergo fibreoptic bronchoscopy examination or treatment under sedation anaesthesia; 3. American Society of Anesthesiologists (ASA) classification of I–III; 4. Stable vital signs before surgery with no significant signs of respiratory distress; 5. Able to understand the study content and sign the informed consent form (or have it signed by a legal representative).

Exclusion criteria

Exclusion criteria: 1. Those allergic to propofol, fospropofol disodium, alfentanil, or other drugs used in the study; 2. Those with severe heart, lung, liver, or kidney dysfunction (such as severe heart failure, respiratory failure, liver or kidney failure); 3. Those with significant airway management difficulties or severe airway stenosis; 4. Those with central nervous system diseases, severe mental disorders, or cognitive impairments who cannot cooperate with sedation assessment; 5. Those with obvious preoperative hypoxemia (SpO2 <90%) or requiring continuous oxygen therapy; 6. Those with a history of severe adverse reactions to sedation and anaesthesia or anaesthesia-related complications; 7. Other conditions deemed unsuitable for inclusion in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Hypoxaemia;

Secondary

MeasureTime frame
Low blood pressure;Time from stopping medication to eye opening, time from stopping medication to recovery of orientation, and time leaving the recovery area;Injection pain, nausea and vomiting, agitation;Mean arterial pressure, heart rate and oxygen saturation before anaesthesia induction (T0), at MOAA/S score <=1 (T1), at laryngoscope insertion to vocal cords (T2), 5 minutes after start of laryngoscop;

Countries

China

Contacts

Public ContactXu Hai

The Second Hospital of Jiaxing

xhjxey@163.com+86 573 82080930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026