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Efficacy and safety of remimazolam besylate for Procedural Sedation and Analgesia in Plastic Surgery

Efficacy and safety of remimazolam besylate for Procedural Sedation and Analgesia in Plastic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125389
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None

Interventions

Midazolam group:Patients in midazolam group received IV midazolam 0.04 mg/kg followed by 0.1 mg/kg/h infusion.
Remimazolam group:Patients in remimazolam group received IV remimazolam 0.2 mg/kg followed by 1 mg/kg/h infusion.

Sponsors

Plastic Surgery Hospital, Chinese Academy of Medical Science & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years; 2. American Society of Anesthesiologists (ASA) physical status class I or II; 3. Patients scheduled to undergo plastic surgery under procedural sedation and analgesia; 4. Ethical, voluntary participation of patients, and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. ASA scores > II; 2. Obesity (Body mass index [BMI] >= 30); 3. Obstructive sleep apnea/hypopnea syndrome; 4. Bradycardia (HR < 50 beat/min); hypotension (Mean arterial pressure [MAP] < 60 mmHg); 5. Severe disease (heart, pulmonary, hepatic or renal); 6. Known allergy to study drugs.

Design outcomes

Primary

MeasureTime frame
The incidence of respiratory depression (RR < 10 breaths/min);

Secondary

MeasureTime frame
Induction time of anesthesia;Lowest respiratory rate;Incidence of oxygen supplementation by facial mask;Incidence of thrusting the jaw;Incidence of hypotension ;Incidence of bradycardia;Frequencies of body movements;Frequencies of additional rescue;Recovery time;Recall of intraoperative events;Pain scores;Satisfaction score of patients;Satisfaction score of surgeons;

Countries

China

Contacts

Public ContactWeipeng Xia

Plastic Surgery Hospital, Chinese Academy of Medical Science & Peking Union Medical College

xiaweipeng0428@163.com+86 185 0019 1219

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026