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Remimazolam besylate for laryngoscopic exposure with the preservation of spontaneous breathing in patients undergoing cervical spine surgery: a prospective, randomized and controlled study.

Remimazolam besylate for laryngoscopic exposure with the preservation of spontaneous breathing in patients undergoing cervical spine surgery: a prospective, randomized and controlled study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086137
Enrollment
Unknown
Registered
2024-06-25
Start date
2024-06-29
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

cervical spine disease

Interventions

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Elective cervical spine surgery 2: Aged 18-65 years 3: ASA grade I-II 4: BMI 18-29 kg/m2 5: modified Mallampati grade ?-? 6: Patients volunteered to participate in the trial and signed informed consent form

Exclusion criteria

Exclusion criteria: 1: Patients with oropharyngeal masses 2: Patients with contraindications to deep sedation/general anesthesia or a previous history of sedation/anesthesia accidents 3: Patients with known allergies to eggs, soy products, opioids and their antidotes, propofol, and remazolam benzenesulfonate; and persons with contraindications to propofol, benzodiazepines, opioids, and their antidotes; 4: History of severe hepatic, renal, digestive, hematologic, neuromuscular, or metabolic disorders that, in the judgment of the investigator, may increase the risk of sedation/anesthesia and make participation in the study unsuitable 5: Long-term use of analgesics, psychiatric system medications (including opioids, NSAIDs, tranquilizers, antidepressants), alcohol abuse, and a history of chronic pain 6: Patients who have participated in a clinical trial of any drug within 1 month prior to screening; 7: Pregnant and lying-in women 8: Electrocardiogram suggesting: heart rate 120 beats/min 9: Monoamine oxidase inhibiting drugs or antidepressants within fifteen days; 10: Abnormal pulmonary function or admission pulse oximetry of 95% or less 11: Subjects who, in the opinion of the investigator, have any other factors that make participation in this clinical study inappropriate

Design outcomes

Primary

MeasureTime frame
respiratory rate;SPO2;

Secondary

MeasureTime frame
Heart rate;Blood pressure;Bispectral index;

Countries

China

Contacts

Public ContactYongzheng Han

Peking University Third Hospital

hanyongzheng@163.com+86 152 0130 4460

Outcome results

None listed

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