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Efficacy and safety of anesthesia induction with fospropofol disodium combined with remimazolam in elderly patients

Efficacy and safety of anesthesia induction with fospropofol disodium combined with remimazolam in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106332
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None

Interventions

experimental group:Inducing the use of fospropofol disodium combined with remimazolam
control group:Inducing the use of propofol disodium combined with remimazolam

Sponsors

The Ninth Affiliated Hospital of Guangxi Medical University, Beihai People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 65-85 years old, gender is not limited; 2. American Society of Anesthesiologists (ASA): I.-III. 3. Body mass index (BMI): 18.5~30 kg/m^2; 4. Surgery under general anesthesia is required, and the expected operation time is more than 30 minutes; 5. Voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have contraindications to general anesthesia or have a history of anesthesia accidents in the past; 2. Combined with brain loss, intracranial hypertension, stroke, unstable angina, myocardial infarction; 3. Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or judged to be difficult to intubate (modified Mars score is grade III or IV); 4. Uncontrolled diabetes or hypertension; 5. History of drug abuse, alcohol abuse or drug dependence; 6. Abuse or long-term use of anesthesia, sedative, and analgesic drugs; 7. Known or suspected allergy or contraindication to various components of the study drug or the process medication specified in the protocol (sufentanil citrate injection, remifentanil hydrochloride for injection, phosphopropofol disodium for injection, etc.); 8. Those with a history of mental illness in the past; 9. Those who have participated in any drug clinical trial within 1 month before screening;

Design outcomes

Primary

MeasureTime frame
Number of successful cases of anesthesia induction;Time when MOAA/S = 1 minute;Eyelash reflex disappearance time;BIS;mean arterial pressure (MAP);Blood oxygen saturation(SPO2);Pulse pressure anomaly(PPV);

Secondary

MeasureTime frame
Anesthesia duration;operative time;

Countries

China

Contacts

Public ContactZhang Shijing

The Ninth Affiliated Hospital of Guangxi Medical University, Beihai People's Hospital

452082490@qq.com+86 185 0779 2607

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026