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Effects of Dexmedetomidine versus Remimazolam Protocolized Sedation Combined with Ultrasound-Guided Lower Limb Nerve Block on Perioperative Stress Response and Postoperative Quality of Recovery in Patients Undergoing Diabetic Foot Ulcer Repair: A Prospective, Randomized Controlled Trial

Effects of Dexmedetomidine versus Remimazolam Protocolized Sedation Combined with Ultrasound-Guided Lower Limb Nerve Block on Perioperative Stress Response and Postoperative Quality of Recovery in Patients Undergoing Diabetic Foot Ulcer Repair: A Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113746
Enrollment
Unknown
Registered
2025-12-02
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Diabetic foot

Interventions

Group B:Intravenous infusion of remimazolam
Group A:Intravenous infusion of dexmedetomidine

Sponsors

Huzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18–75 years, any gender; 2. Anesthesia ASA classification II–III; 3. Fasting blood glucose controlled between 4.0–11.0 mmol/L; 4. Body mass index (BMI) normal (18.5–30 kg/m^2); 5. Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe respiratory and circulatory system diseases; 2. Coagulation dysfunction (including PT, INR, and APTT exceeding 1.5 times the normal value, platelet count below 80×10^9/L); 3. History of allergic reaction to local anesthetics; 4. History of drug abuse (including opioids and psychoactive drugs); 5. History of peripheral nerve injury in the lower limbs and infection at the operation site; 6. Vulnerable groups.

Design outcomes

Primary

MeasureTime frame
Cortisol;

Secondary

MeasureTime frame
Stress-related physiological parameters (including mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO?), respiratory rate (RR), etc.);Patient and healthcare provider satisfaction assessment;Assessment of intraoperative stress levels;Postoperative recovery quality;Postoperative pain intensity;

Countries

China

Contacts

Public ContactTang Yawen

Huzhou Central Hospital

tyw322206@163.com+86 184 5725 1003

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 9, 2026