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Clinical study of propofol and remazolam in painless gastrointestinal endoscopy in elderly patients : a two-center, single-blind, randomized controlled trial

Clinical study of propofol and remazolam in painless gastrointestinal endoscopy in elderly patients : a two-center, single-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122330
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Study on anesthetic sedative drugs

Interventions

Cyclopophenol group:In the ciprofol group, induction was performed with slow intravenous injection of 1 µg/kg fentanyl (up to 50 µg) and 0.2 mg/kg ciprofol until the patient fell asleep and the eyelas
Remazolam group:In the remimazolam group, induction was performed with slow intravenous injection of 1 µg/kg fentanyl (up to 50 µg) and 0.2–0.3 mg/kg remimazolam. For maintenance of anesthesia, supple

Sponsors

Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years 2. Accept elective painless gastroscopy or colonoscopy or gastrointestinal endoscopy diagnosis and treatment 3.ASA grade I or II. 4.It is estimated that the operation time of gastrointestinal endoscopy not exceed 60 minutes. 5.Clear understanding, voluntary participation in this study, and signed informed consent

Exclusion criteria

Exclusion criteria: 1.Complicated endoscopic diagnosis and treatment techniques ( such as cholangiopancreatography, endoscopic mucosal resection, endoscopic submucosal dissection, transoral endoscopic myotomy, etc. ) ; 2.Patients undergoing tracheal intubation ; there are serious heart diseases such as severe arrhythmia, heart failure, A-S syndrome, unstable angina pectoris, myocardial infarction in the past 6 months, tachycardia / bradycardia history requiring drug treatment, and third-degree atrioventricular block ; 3.History of hypertension or admission measured systolic blood pressure >= 180mmHg or / and diastolic blood pressure >= 110mmHg ; 4.Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute respiratory tract infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough ; 5.There is an uncontrolled history of diseases with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which the researchers determine may not be suitable for the study ; 6.Known allergies to eggs, bean products, benzodiazepines and their components, opioids and their rescue drugs ; 7.3 months had a history of alcoholism ; 8.Cerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysms, cerebrovascular accident history ; 9.Schizophrenia, mental retardation, mania, mental disorders, myasthenia gravis, severe depression, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction and other patients ; 10.Researchers believe that patients should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension ( systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg );

Secondary

MeasureTime frame
The duration of hypotension value;Hypoxemia ( < 90 % );Incidence of injection pain;Induction time;Examination time;Anesthesia time;Recovery time;Patients satisfaction;Physician satisfaction;

Countries

China

Contacts

Public ContactZhu Qianqian

Seventh Affiliated Hospital of Sun Yat-sen University

zhu.qian.qian123@stu.xjtu.edu.cn+86 180 3307 2683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026