Comparison of remazolam besylate and propofol in general anesthesia with tracheal intubation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200058488

Enrollment

Unknown

Registered

2022-04-10

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-05-12

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

Conditions

None listed

Interventions

Control group:induction and maintenance with propofol

Experimental group:induction and maintenance with remazolam besylate

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years, gender is not limited; 2. BMI 18.5-30 kg/m2; 3. ASA I and II level; 4. Subjects undergoing elective general anesthesia and requiring endotracheal intubation; 5. Non-acute hospitalized subjects who have undergone proper preoperative preparation; 6. The expected operation time is 2-3 hours; 7. Voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have long-term use of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) and alcohol abusers for chronic pain; 2. The weight is lower than or exceeds 15% of the standard weight; 3. Abnormally increased preoperative liver and kidney functions (ALT, AST, BUN, Cr); 4. Previous history of recovery from anesthesia for abnormal operations; 5. Have a history of hypertension in the past or enter the operating room to measure systolic blood pressure greater than 160 mmHg or diastolic blood pressure less than 95 mmHg; 6. Suffering from esophageal reflux disease; 7. Sedatives, analgesics, and antipruritic drugs were used 24 hours before the operation; 8. Difficult intubation is expected; 9. Perform liver surgery; 10. Have a history of opioid allergy; 11. Taking monoamine oxidase inhibitors or antidepressants within 15 days; 12. Shock subjects; 13. COPD subjects; 14. Pregnant women or mothers; 15. Participated in other drug trials within three months.

Design outcomes

Primary

Measure	Time frame
The time between the end of administration and the patient's complete awakening;	—

Secondary

Measure	Time frame
Vital signs;Sedation related indexes;Time related indicators: loss of consciousness time/ time to open eyes/time to wake up;	—

Countries

China

Contacts

Public ContactTian Dandan

The First Affiliated Hospital of Zhengzhou University

ddt0802@163.com+86 13939071527

Outcome results