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Comparing the Efficacy and Safety of Propofol and Remimazolam during Rapid Sequential Intubation Induction: A Prospective, Randomized Controlled, Non-Inferiority Trial

Comparing the Efficacy and Safety of Propofol and Remimazolam during Rapid Sequential Intubation Induction: A Prospective, Randomized Controlled, Non-Inferiority Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113636
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-08
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

Anesthesia, rapid sequential induction

Interventions

remimazolam besylate group:Start sedation and analgesia with a combination of 0.3mg/kg remimazolam besylate combined with 1mg/kg rocuronium bromide, 1ug/kg remifentanil, and 1mg/kg lidocaine
propofol group:Start sedation and analgesia with a combination of 2mg/kg propofol combined with 1mg/kg rocuronium bromide, 1ug/kg remifentanil, and 1mg/kg lidocaine

Sponsors

Xiamen Hospital of Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Elective non-cardiac surgery patients; 2. Requiring endotracheal intubation for induction of general anaesthesia; 3. No gender restrictions, aged 18 to 65 years; 4. American Society of Anesthesiologists (ASA) physical status classification I–III; 5. Mallampati airway classification I–II; 6. Voluntary participation with signed informed consent; 7. Patients for whom rapid sequence induction (RSI) is clinically indicated during routine management, such as: those with full stomachs, intestinal obstruction, altered mental status, concomitant hiatal hernia, or requiring urgent surgery without adequate preoperative fasting.

Exclusion criteria

Exclusion criteria: 1. Individuals with respiratory tract infections within the past 14 weeks, or those using corticosteroids or bronchodilators; 2. Patients predicted to have difficult airways; 3. BMI >= 35 kg/m²; 4. Patients with myasthenia gravis, schizophrenia, or major depressive disorder; 5. History of allergy to opioid medications, propofol, or components of remimazolam (namely soybean oil, glycerol, triglycerides, egg yolk lecithin, sodium oleate, and sodium hydroxide).

Design outcomes

Primary

MeasureTime frame
Evaluation of intubation conditions: excellent, good, poor;

Secondary

MeasureTime frame
Incidence of Post-Induction Hypotension;Sedation onset time;Initial Dose Induction Success Rate;Incidence of Injection Pain;Incidence of Postoperative Sore Throat;Use and Frequency of Use of Study Drug Supplementary Doses and/or Rescue Medications;

Countries

China

Contacts

Public ContactHong Weifeng

Xiamen Hospital of Zhongshan Hospital Affiliated to Fudan University

hong.weifeng@zsxmhospital.com+86 136 0605 2052

Outcome results

None listed

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