Safety and efficacy of remimazolam besylate in patients undergoing orthopedic surgery under spinal anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300067722

Enrollment

Unknown

Registered

2023-01-19

Start date

2023-01-20

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Lower limb surgery for orthopedic diseases

Interventions

Remimazolam group (R group):remimazolam besylate

Propofol group (P group):Propofol

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily participate and sign the informed consent form; 2. Aged 18-65 years; 3. ASA is classified as I-II; 4. Body mass index (BMI) 19-30 kg/m2; 5. Patients who plan to undergo orthopedic surgery under spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1. Have a history of mental illness or take psychotropic drugs; 2. Intraspinal anesthesia contraindication; 3. Pregnant or lactating women; 4. Contraindications to anesthetic drugs in this study; 5. Sleep apnea syndrome; 6. Systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse reactions;Brain bispectral index;	—

Secondary

Measure	Time frame
Sedative dosage;Observe and record the changes of systolic blood pressure, diastolic blood pressure, heart rate, BIS value and SpO2 ;	—

Countries

China

Contacts

Public ContactXiaoqiang Zhang

Mengcheng County First People's Hospital

zxqahl@126.com+86 13309670321

Outcome results

None listed

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