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Effects of remimazolam tosilate or propofol combined with esketamine on intraoperative hypotension in patients undergoing laparoscopic surgery: a multicenter, randomized controlled clinical trial

Effects of remimazolam tosilate or propofol combined with esketamine on intraoperative hypotension in patients undergoing laparoscopic surgery: a multicenter, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073619
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-17
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Intraoperative hypotension

Interventions

Propofol group:Propofol
Remimazolam combined with esketamine group:Remimazolam combined with esketamine
Remimazolam group:Remimazolam
Propofol combined with esketamine group:Propofol combined with esketamine

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 < age =65 years old, regardless of gender; 2. Planned laparoscopic (tracheal intubation) surgery, the expected duration of anesthesia was 1-3 hours; 3. ASA grade ? or ?; 4. 18 kg/m2 < BMI < 30 kg/m2; 5. Understand and voluntarily participate in the study, and sign the informed consent form by themselves.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; Hypovolemia, shock or coma; 2. In addition to general intravenous anesthesia, other anesthesia methods should be combined, such as inhalation, epidural, subarachnoid anesthesia, etc. 3. Infectious heart diseases such as myocarditis or endocarditis, septicemia; 4. Cardiopulmonary bypass was planned; Heart, liver and kidney transplants were planned. The type of planned operation may affect the collection of BIS index. 5. Patients with large estimated intraoperative blood loss; 6. Abnormal coagulation function; 7. Anemia or thrombocytopenia; 8. Abnormal liver and kidney function; 9. Complicated with acute heart failure, unstable angina and other cardiovascular diseases; 10. Patients with hypertension and hypotension whose blood pressure is not adequately controlled; 11. Patients with a history of craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident, or central nervous system disease; 12. Diabetic patients with inadequate glycemic control; 13. A history of drug abuse and/or alcohol abuse within 2 years before screening; 14. Patients with mental disorders, long-term use of psychotropic drugs and cognitive impairment; 15. Pregnant or lactating women; 16. Allergic or contraindicated to benzodiazepines, opioids, propofol, esketamine, muscle blockers and other drugs and their components; 17. Patients judged to have airway management difficulties; 18. Any other circumstances that the investigator considered inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
The incidence of intraoperative hypotension;

Secondary

MeasureTime frame
The success rate of anesthesia;Anesthesia induction time;Anesthesia recovery time;Time to leave PACU;Dosage of sedatives;Dose of opioids;Dosage of vasoactive agents;Intraoperative blood loss;Agitation score after extubation and extubation;VAS pain score after extubation;Orientation score and orientation recovery time after extubation;Satisfaction with anesthesia;The scores of QoR-15 scale on d1, d3 and d30 after surgery;Time-weighted mean of intraoperative hypotension;The number of hypotensive events per patient;The total time of intraoperative hypotension;The percentage of time hypotension occurred;Adverse event;BIS changes;

Countries

China

Contacts

Public ContactMiao Changhong

Zhongshan Hospital, Fudan University

miao.changhong@zs-hospital.sh.cn+86 136 8197 5062

Outcome results

None listed

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