Clinical application of sedation during induction of anesthesia in adult cardiac surgery patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050122

Enrollment

Unknown

Registered

2021-08-16

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-04-25

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

Conditions

None listed

Interventions

intervention group:Remimazolam Tosilate

control group 1:Midazolam

control group 2:Etomidate

Eligibility

Sex/Gender

All

Age

45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 45 to 80 years; 2. Elective heart valve surgery under cardiopulmonary bypass; 3. ASA grade III-IV and cardiac function III-IV; 4. 18 kg/m^2<BMI<30kg/m^2; 5. Clearly understand and voluntarily participate in the research, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hypovolemia, shock or coma; 2. Acute heart failure; unstable angina; myocardial infarction within 6 months before screening; resting ECG heart rate = 450 ms, female >= 470 ms ; 3. Infectious heart disease such as myocarditis or endocarditis; sepsis; 4. Patients with severe angina pectoris and arrhythmia in the past; 5. Hypertensive patients whose blood pressure is not satisfactorily controlled by antihypertensive drug treatment (sitting systolic blood pressure >=160 mmHg during screening period, and/or diastolic blood pressure >=100 mmHg during screening period); 6. Sitting systolic blood pressure =1.5xULN, APTT >=1.5xULN); 8. Anemia or thrombocytopenia, Hb=2.5xULN, TBIL>=1.5xULN; 10. Abnormal renal function, urea or urea nitrogen >=1.5xULN, serum creatinine greater than the upper limit of normal; 11. Those who suffer from mental system diseases (schizophrenia, mania, bipolar disorder, insanity, etc.) and long-term use of psychotropic drugs and cognitive dysfunction; 12. Patients who are pregnant or breastfeeding; 13. Those who are allergic to or have contraindications to benzodiazepines, opioids, propofol, muscle relaxants and other drugs and their components; 14. Patients who are judged to have difficulty in airway management (modified Markov score is grade IV); 15. Participated in drug clinical trials as patients within the past 3 months; 16. Other circumstances in which the investigator considers it inappropriate to participate in this trial.

Design outcomes

Primary

Measure	Time frame
Incidence of hypotension;	—

Secondary

Measure	Time frame
Induction success rate;Induction period cough rate;Postoperative low cardiac output syndrome;In-hospital mortality;	—

Countries

China

Contacts

Public ContactLiu Bin

West China Hospital of Sichuan University

liubinhx@163.com+86 18980601540

Outcome results