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Effect of Remimazolam Besylate on Hemodynamics during Anesthesia Induction and Maintenance in Patients Undergoing Laparoscopic Surgery

Effect of Remimazolam Besylate on Hemodynamics during Anesthesia Induction and Maintenance in Patients Undergoing Laparoscopic Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109128
Enrollment
Unknown
Registered
2025-09-12
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Patient undergoing laparoscopic surgery under general anesthesia

Interventions

Experimental Group one:Remimazolam: Induction with 0.1 mg/kg/min
Maintenance with 1–2 mg/kg/h.
Experimental Group two:Remimazolam: Induction with 0.2mg/kg/min
Control Group:Propofol: Induction 2.5 mg/kg
Maintenance 4–12 mg/kg/h.

Sponsors

Changzhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, regardless of gender; 2. Scheduled for elective laparoscopic surgery under general anesthesia; 3. ASA physical status 18 kg/m^2 and <30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1.Emergency surgery; 2.Planned open laparotomy or intraoperative conversion to laparotomy; 3.Hypertensive patients with uncontrolled blood pressure despite antihypertensive medication (Systolic BP >=160 mmHg and/or Diastolic BP >=100 mmHg); 4.Laboratory abnormalities: Anemia (Hb =2.5 × ULN; TBIL >=1.5 × ULN); Renal dysfunction (Serum creatinine > upper limit of normal); 5.Acute angle-closure glaucoma, myasthenia gravis, or acute alcohol intoxication; 6.Shock (Systolic BP <=90 mmHg) or comatose patients; 7.History of benzodiazepine allergy or tolerance; 8.Pregnant or lactating women; 9.Procedures requiring cardiopulmonary bypass, hepatectomy, or liver transplantation; 10.Participation in other drug clinical trials within 3 months prior; 11.Patients deemed ineligible by investigator or who decline participation.

Design outcomes

Primary

MeasureTime frame
Cardiac Index;

Secondary

MeasureTime frame
Induction dose (remimazolam/propofol) at loss of consciousness;Modified Observer's Assessment of Alertness/Sedation Scale;Mean arterial pressure,MAP;Stroke volume index, SVI;Systemic vascular resistance index, SVRI;

Countries

China

Contacts

Public ContactLi QIudong

Changzhou Cancer Hospital

956654615@qq.com+86 138 1503 9291

Outcome results

None listed

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