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Efficacy and safety of remazolam toluenesulfonate for emergency endoscopic treatment of upper gastrointestinal bleeding due to portal hypertension in cirrhosis: a single-center randomized controlled clinical trial

Efficacy and safety of remazolam toluenesulfonate for emergency endoscopic treatment of upper gastrointestinal bleeding due to portal hypertension in cirrhosis: a single-center randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048620
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Hemorrhage of esophageal and gastric fundus varices in cirrhosis

Interventions

The propofol group:Propofol: initial dose 1.5mg/kg, supplementary dose 0.5mg/kg/ time (no more than 6 times)
remazolam tosylate:Remazolam toluene sulfonate: initial dose of 5mg, additional dose of 2.5mg/ time (additional times not more than 6 times)
remazolam tosylate:Remazolam toluene sulfonate: initial dose of 7mg, additional dose of 2.5mg/ time (additional times not more than 6 times)
remazolam tosylate:Remazolam toluene sulfonate: initial dose of 8mg, additional dose of 2.5mg/ time (additional times not more than 6 times)

Sponsors

Xuchang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years(including upper and lower limits); 2. According to the medical history (previous history of liver cirrhosis), physical examination, auxiliary examination results (color Doppler ultrasound, liver and kidney function, blood routine) clinical manifestations (acute hematemesis, melena) diagnosed as acute upper gastrointestinal bleeding due to portal hypertension of liver cirrhosis ; 3. Those who intend to undergo emergency endoscopic hemostasis; 4. Those who signed the informed consent and voluntarily cooperated with those who completed the experiment according to the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with upper gastrointestinal bleeding caused by other reasons (cardiac tear, gastric ulcer, gastric cancer); 2. Those who have previously undergone portosystemic shunt or splenectomy; 3. Women who are pregnant or breastfeeding; 4. Other conditions in which the researcher believes that the patient is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Sedation induction time, sedation recovery time;modified alertness/sedation score;Satisfaction of endoscopists with surgical procedures;nausea and vomiting;—

Countries

China

Contacts

Public ContactWang Huaqiang

Xuchang Central Hospital

wang2869009@163.com+86 13903746239

Outcome results

None listed

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