Skip to content

A Prospective Randomized Controlled Study: Comparison of the Effects of Low-Dose Remimazolam or Midazolam Combined with Propofol in the Induction of Anesthesia for Total Mastectomy

A Prospective Randomized Controlled Study: Comparison of the Effects of Low-Dose Remimazolam or Midazolam Combined with Propofol in the Induction of Anesthesia for Total Mastectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123407
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Patients undergoing total mastectomy

Interventions

Remimazolam + Propofol group:Intravenous sufentanil 0.3µg/kg, followed by intravenous remimazolam 0.1 mg/kg. Target-controlled infusion (TCI) of propofol is started 2 minutes later.
Midazolam + Propofol group:Intravenous sufentanil 0.3µg/kg, followed by intravenous midazolam 0.05 mg/kg. Target-controlled infusion (TCI) of propofol is started 2 minutes later.
Propofol alone group:Intravenous sufentanil 0.3µg/kg, followed by intravenous normal saline 5ml. Target-controlled infusion (TCI) of propofol is started 2 minutes later.

Sponsors

Jieyang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Planned elective unilateral total mastectomy; 2. Patient and their legal representative voluntarily participate in the study and have signed the informed consent form; 3. Preoperative ASA (American Society of Anesthesiologists) classification: Class I–II; 4. Age: 18–75 years; 5. Have not participated in other drug clinical trials in the 3 months prior to surgery.

Exclusion criteria

Exclusion criteria: 1. History of allergy to related experimental drugs; 2. Severe liver and kidney dysfunction (Child-Pugh class C or eGFR <30 mL/min); 3. BMI =35 kg/m^2; 4. Long-term use of benzodiazepines or opioids; 5. Preoperative cognitive impairment (MoCA <26 points); 6. History of alcohol or drug abuse; 7. Difficult airway; 8. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension during induction;

Secondary

MeasureTime frame
Quality of induction and recovery profile(Record the time of loss of consciousness, endotracheal intubation condition score, total propofol induction dose, and postoperative spontaneous breathing recovery time, extubation time, and orientation recovery time);

Countries

China

Contacts

Public ContactZhexuan Chen

Jieyang People's Hospital

chenzx1993@stu2023.jnu.edu.cn+86 158 1967 2275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026