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Effects of Remimazolam Besylate on Cardiac Output in COPD Patients Undergoing Laparoscopic Surgery

A single-center, double-blind, randomized, parallel-controlled study assessing the impact of remimazolam besylate on the central output of patients with chronic obstructive pulmonary disease undergoing laparoscopic surgery.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109433
Enrollment
Unknown
Registered
2025-09-18
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Experimental group:General anesthesia with Remimazolam Besylate

Sponsors

Shanghai First People's Hospital Jiuquan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2. Consistent with COPD diagnosis; 3. Laparoscopic surgery under general anesthesia at an elective stage; 4. American Society of Anesthesiologists (ASA) grade I.-III; 5. Agree to participate in this trial and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI) >=30 kg/m²; 2. History of brain or thoracic/abdominal aortic aneurysm; 3. Allergy to any drug used in this study; 4. History of severe hepatic impairment, i.e., Child-Pugh grade C; 5. Currently receiving maintenance dialysis treatment; 6. Congestive heart failure, NYHA cardiac function class III or IV. 7. Untreated or unstable ischemic heart disease; 8. History of severe aortic or mitral valve disease; 9. History of frequent premature ventricular contractions, frequent atrial premature contractions or atrial fibrillation; 10. Current use of antidepressants or antipsychotics; 11. Mean arterial pressure (MAP) < 70 mmHg before anesthesia induction; 12. Presence or anticipation of airway management difficulties; 13. Failure of first intubation; 14. Judged by the investigator to be ineligible for inclusion; 15. Absolute contraindications to TEE (history of esophageal stricture, variceal bleeding, etc.); 16. Pregnant or lactating women; 17. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Cardiac Output (CO);Right ventricular area change fraction(RV-FAC);Tricuspid Annular Plane Systolic Excursion (TAPSE);Right Ventricular Diastolic Function (E/e');

Secondary

MeasureTime frame
Mean Arterial Pressure (MAP);Heart Rate (HR);Pulse oxygen saturation(SpO?);Research on total drug dosage;Total dosage of Vasoactive Drugs;Anesthesia recovery time;Incidence of adverse events;

Countries

China

Contacts

Public ContactChen Fu

Shanghai First People's Hospital Jiuquan Hospital (Jiuquan People's Hospital)

13659366621@163.com+86 136 5936 6621

Outcome results

None listed

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