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A Randomized Controlled Study on the Safety and Efficacy of Remimazolam Besilate or Midazolam Combined with Remifentanil in Emergency Rapid Sequence Induction of Tracheal Intubation

A Randomized Controlled Study on the Safety and Efficacy of Remimazolam Besilate or Midazolam Combined with Remifentanil in Emergency Rapid Sequence Induction of Tracheal Intubation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105484
Enrollment
Unknown
Registered
2025-07-04
Start date
2025-07-08
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

None

Interventions

Experimental group:Remimazolam besilate for emergency rapid sequence induction of tracheal intubation
Control group:Midazolam is used for emergency rapid sequence induction of tracheal intubation.

Sponsors

Deyang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 80 years old; 2) The researcher evaluates that the patient requires emergency RSI due to the condition; 3) The patient's family consents to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Patients allergic to remifentanil, remimazolam besilate, or midazolam; 3) Patients identified as having a high-level difficult airway according to the LEMON assessment method; 4) Patients with myasthenia gravis; 5) Other conditions deemed unsuitable for enrollment by the researcher.

Design outcomes

Primary

MeasureTime frame
The success rate of one-time intubation (the success rate of one-time intubation = the number of successful one-time intubation cases / the total number of cases * 100%);The time required for successful one-time intubation (intubation time is timed from the moment the laryngoscope enters the oral cavity until the tracheal tube is properly fixed);—

Secondary

MeasureTime frame
Intubation time;The administration time of RSI induction drugs;CPOT score 5 minutes before intubation;CPOT score 5 minutes after intubation;CPOT score 15 minutes after intubation;CPOT score 30 minutes after intubation;RASS score 5 minutes before intubation;RASS score 5 minutes after intubation;RASS score 15 minutes after intubation;RASS score 30 minutes after intubation;Heart rate 5 minutes before intubation;Heart rate 5 minutes after intubation;Heart rate 15 minutes after intubation;Heart rate 30 minutes after intubation;5 minutes before intubation, diastolic blood pressure;Diastolic blood pressure 5 minutes after intubation;Diastolic blood pressure 15 minutes after intubation;Diastolic blood pressure 30 minutes after intubation;Mean arterial pressure 5 minutes before intubation;Mean arterial pressure 5 minutes after intubation;Mean arterial pressure 15 minutes after intubation;Mean arterial pressure 30 minutes after intubation;Total amount of analgesic and sedative drugs 5 minutes before intubation;Total amount of analgesic and sedative drugs 5 minutes after intubation;Total amount of analgesic and sedative drugs 15 minutes after intubation;Total amount of analgesic and sedative drugs 30 minutes after intubation;Whether to administer additional medication;Number of additional administrations;Additional dosage;—

Countries

China

Contacts

Public ContactHe Dingxiu

Deyang People's Hospital

2467628393@qq.com+86 159 8494 1509

Outcome results

None listed

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