Skip to content

Canceled by the investigator. Remazolam for restiness during recovery of adult patients undergoing short otorhinolaryngologic surgery

Remazolam for restiness during recovery of adult patients undergoing short otorhinolaryngologic surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067740
Enrollment
Unknown
Registered
2023-01-19
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Ear, nose and throat disease

Interventions

P group:Intravenous induction of propofol 2kg/mg, Anesthesia maintenance: propofol 4mg/kg/h, remifentanil 0.2 µg/kg/min
R group:Intravenous induction of remazolam 0.3kg/mg, Anesthesia maintenance: remazolam 1mg/kg/h, remifentanil 0.2µg/kg/min

Sponsors

The Third People's Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. ASA I-II; 3. Who were scheduled for elective short otorhinolaryngologic surgery; 4. Support laryngoscopic surgery (support laryngoscopic excision of epiglottic cyst, support laryngoscopic excision of glottic polyp), endoscopic septoplasty, endoscopic tympanoplasty, and endoscopic middle ear catheterization were planned, and the operation time was not more than 90 minutes.

Exclusion criteria

Exclusion criteria: 1. The patient had severe heart, brain, kidney, lung and liver diseases and refractory hypertension; 2. Severe bradycardia, heart rate < 50 times/min; 3. Suffering from mental illness and long-term use of psychotropic drugs; 4. Cognitive dysfunction; 5. Allergic or contraindicated to the components of benzodiazepines; 6. Used other sedatives in the last week.

Design outcomes

Primary

MeasureTime frame
Sedation agitation score;Spontaneous breathing recovery time;Waking time;Extubation time;

Secondary

MeasureTime frame
Hemodynamic changes ;Adverse reaction indicators: postoperative hypotension, hypoxemia, bradycardia, dizziness, lethargy, nausea and vomiting;

Countries

China

Contacts

Public ContactYu Di

The Third People's Hospital of Hubei Province

617275819@qq.com+86 15612181994

Outcome results

None listed

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