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Comparison of the Application of Fospropofol Disodium Combined with Remimazolam Versus Propofol in General Anesthesia Induction in Elderly Patients: A Randomized Non-Inferiority Trial

Comparison of the Application of Fospropofol Disodium Combined with Remimazolam Versus Propofol in General Anesthesia Induction in Elderly Patients: A Randomized Non-Inferiority Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126428
Enrollment
Unknown
Registered
2026-06-09
Start date
2026-07-30
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Fospropofol disodium

Interventions

Propofol group:Anesthesia induction was performed using propofol for sedation.
Remimazolam combined with fospropofol group:Anesthesia induction was performed using remimazolam combined with fospropofol disodium.

Sponsors

People's Hospital of Jianyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60 to 89 years; 2. Scheduled to undergo elective laparoscopic surgery under general anesthesia with endotracheal intubation; 3. Body mass index (BMI) of 18 to 30 kg/m²; 4. American Society of Anesthesiologists (ASA) physical status classification ? to ?; 5. Voluntary participation in this trial and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of allergy to any medications used in the study; 2. History of neurological or psychiatric disorders, or long-term use of sedative agents; 3. History of severe cardiovascular diseases (e.g., coronary heart disease with chest tightness or angina pectoris, heart failure, or severe arrhythmia); 4. Uncontrolled hypertension (systolic blood pressure [SBP] = 160 mmHg or diastolic blood pressure [DBP] = 100 mmHg); 5. Abnormal liver function (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] = 1.5 × upper limit of normal [ULN], total bilirubin [TBIL] = 1.5 × ULN); 6. Abnormal renal function (blood urea nitrogen [BUN] = 1.5 × ULN or creatinine [Cr] = 1.2 × ULN); 7. Suspected difficult airway (modified Mallampati classification Grade ?); 8. Any other conditions deemed unsuitable for study participation by the investigators.

Design outcomes

Primary

MeasureTime frame
Time to reach 1 point on the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S);

Secondary

MeasureTime frame
Changes in hemodynamics;Eyelash reflex disappearance time;The time when the Bispectral Index (BIS) depth of anesthesia drops to 60;Length of stay in the post-anesthesia care unit;Adverse effects;recover time;

Countries

China

Contacts

Public ContactWenjie Mao

People's Hospital of Jianyang City

35917029@qq.com+86 28 2723 8006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026