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Safety and dose exploration of remazolam tosylate for induction and maintenance of general anesthesia in elective short-term surgery in adults: a multi-center, randomized, double-blind clinical study

Safety and dose exploration of remazolam tosylate for induction and maintenance of general anesthesia in elective short-term surgery in adults: a multi-center, randomized, double-blind clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053258
Enrollment
Unknown
Registered
2021-11-17
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

General anesthesia induction and maintenance of elective short-term surgery in adults

Interventions

Group A:During the induction period, remazolam 0.1 mg/kg was administered intravenously for 60 seconds
Group B:During the induction period, remazolam 0.15 mg/kg was administered intravenously for 60 seconds
Group C:During the induction period, remazolam 0.2 mg/kg was administered intravenously for 60 seconds

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASA I-III; 2. Aged 18-65 years; 3. Gender is not limited; 4. Planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septum plasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection, general anesthesia intubation patients; 5. Operation time <= 90 min.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Abnormal renal function (blood urea nitrogen >= 1.5 x ULN, serum creatinine greater than the upper limit of normal); 3. Abnormal liver function; 4. Hypovolemia, shock or coma; 5. Suffering from mental system diseases and long-term use of psychotropic drugs; 6. Cognitive dysfunction; 7. Those who are allergic to or have contraindications to the components of benzodiazepines; 8. Pregnant or lactating female patients; 9. Have a history of drug dependence; 10. Use of other sedative drugs in the past week; 11. Participated in drug clinical trials as subjects within the past 3 months.

Design outcomes

Primary

MeasureTime frame
The incidence of hypotension in the induction and maintenance phases;Sedation success rate of remazolam tosylate in the induction and maintenance phases;

Secondary

MeasureTime frame
Ttime for BIS(bispectral index) to drop to 40-60;Frequency and duration ratio of intraoperative hypotension;Intraoperative awareness rate;Ratio of occurrences and duration of BIS > 60 and BIS < 40;Time from drug withdrawal to recovery of consciousness (waking time);Time from start of drug injection to complete disappearance of consciousness;Time for MOAA(modified observer’s assessment of alert)/S score to 0;

Countries

China

Contacts

Public ContactGong Xingrui

Xiangyang Central Hospital

40415311@qq.com+86 15071551981

Outcome results

None listed

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