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A randomized, controlled, single-blind, single-center clinical study to evaluate the safety and efficacy of remazolam tosylate for sedation during laparoscopic cholecystectomy

A randomized, controlled, single-blind, single-center clinical study to evaluate the safety and efficacy of remazolam tosylate for sedation during laparoscopic cholecystectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104101
Enrollment
Unknown
Registered
2025-06-11
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Gallstones or cholecystitis

Interventions

Experimental group:Remazolam toluenesulfonate group for injection: Induction of anesthesia: Intravenous injection of remazolam toluenesulfonate 0.2 mg/kg, Sufentanil citrate injection 0.3µg/kg and roc
Control group:Propofol emulsion injection: Anesthetic induction: Propofol emulsion injection 2 mg/kg, Sufentanil citrate injection 0.3µg/kg and rocuronium bromide injection 0.8mg/kg were injected intr

Sponsors

Jintang County first People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1, 18<= age < 60 years old, gender is not limited; 2. A clear diagnosis requires elective laparoscopic cholecystectomy (LC) treatment. 3. No cognitive behavior disorder; 4, ASA II or III, the expected time of surgery is less than 2 hours; 5. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to drugs used in this study; 2. People with mental or nervous system diseases; 3. People who are dependent on or tolerant to opioids; 4, serious cardiovascular system, respiratory system, liver and kidney diseases; 5. Participated in or is participating in other drug clinical trials within the last 3 months; 6. Pregnant or lactating women; 7. Those who are not considered suitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension;

Secondary

MeasureTime frame
Time to reach the goal of sedation;Subject's sedation and recovery time;RASS sedative agitation score;MAP,HR,BIS,SPO2;CRP, C-reactive protein;

Countries

China

Contacts

Public ContactLi Deyuan

First People's Hospital of Jintang County, Sichuan Province

1839077375@qq.com+86 159 0819 8639

Outcome results

None listed

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