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A single-center, randomized, double-blind and positive drug parallel controlled clinical study on the effect of remidazolam on short-term sleep after painless gastroscopy in elderly patients

A single-center, randomized, double-blind and positive drug parallel controlled clinical study on the effect of remidazolam on short-term sleep after painless gastroscopy in elderly patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068782
Enrollment
Unknown
Registered
2023-02-28
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Painless gastroscopy

Interventions

Experimental group RR1:remifentanil 0.3µg/kg + remazolam 0.2mg/kg iv
0.05mg/kg per 5min iv remazolam, 0.3µg/kg for remifentanil every 10 minutes. If the subjects move and obviously swallow during the operation, 0.05mg/kg of reimazolam toluene sulfonate will be added on
Experimental group RR2:Remifentanil 0.3µg/kg + reimazolam 0.25mg/kg iv
0.05mg/kg per 5min iv and 0.3µg/kg for remifentanil every 10 minutes. If the subjects move and obviously swallow during the operation, 0.05mg/kg of reimazolam toluene sulfonate will be added one after
Experimental group RR3:Remifentanil 0.3µg/kg + remazolam 0.3mg/kg iv
0.05mg/kg for every 5min iv and 0.3µg/kg for remifentanil every 10 minutes. If the subjects move and obviously swallow during the operation, 0.05mg/kg of reimazolam toluene sulfonate will be added one
Control group:Propofol 2.0mg/kg + remifentanil 0.3µg/kg, iv.
0.5mg/kg per 5min iv propofol. Add 0.3µg/kg to remifentanil every 10 minutes. If the subjects move and obvious swallow during the operation, 0.5mg/kg of propofol will be added one by one until they re

Sponsors

Northern Jiangsu People's Hospital Anesthesiology Department
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age =60 years old 2) There is no gender limit; 3) Patients undergo routine gastroscopy and simple gastroscopy diagnosis and treatment, such as taking pathological specimens; 4) ASA grade I-II; 5) 18kg/m2<BMI<30 kg/m2; 6) Informed consent, voluntarily participate in the trial, and the patient shall sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1) Endoscopic diagnosis and treatment techniques with complex or harmful stimulation need to be carried out (such as pancreatic cholangiography, ultrasound endoscopy, endoscopic mucosal resection, endoscopic submucosal detachmentation, transoroscopy, upper gastrointestinal foreign body removal, esophageal varicose vein ligation, upper gastrointestinal hemostatic surgery, esophageal stenosis Zhang Shu, etc.); 2) The operating time is expected to be >20min; 3) The patient has severe communication disorders caused by severe hearing degradation; 4) During the operation, it is expected to use drugs other than preoperative preparation, sedative plan and saline (such as Lugo's liquid/indigo rouge/methyl blue/acetic acid-assisted magnifying gastroscopy and early cancer screening may be sprayed during the operation; it may be due to the large number of biopsy cases and the large wounds, and The wound needs to be sprayed with norepinephrine to stop bleeding; there is an uncontrolled atrial fibrillation before the operation, and it is expected that rapid ventricular rate atrial fibrillation may occur during the operation, requiring drug treatment, etc.); 5) The patient has a history of severe dizziness and severe dizziness; 6) Subjects have limited neck movement, how short the chin distance ( 40% liquor / 150ml wine); 8) The patient expressly refused to participate in this study; 9) Participated in clinical trials of other drugs or instruments within 3 months before the screening period; 10) The patient did not elution and take banned drugs as required; 11) The patient cannot be clear whether he has taken banned drugs within the past 7 days; 12) Patients who believe that it is not appropriate for researchers to participate in this study; 13) ASA grading level III or above;

Design outcomes

Primary

MeasureTime frame
Number of sleeps within 48 hours after surgery;Total sleep time within 48 hours after surgery;Length of sleep and sleep quality within 48 hours after surgery;

Secondary

MeasureTime frame
Anesthesia process satisfaction;Severity and recovery time of the discomfort symptoms;

Countries

China

Contacts

Public ContactLiu Xin

Ethics Committee of Northern Jiangsu People's Hospital

615389622@163.com+86 18952578285

Outcome results

None listed

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