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Study on the safety of opioid-free anesthesia in elderly patients during gastrointestinal endoscopy:a prospective multicenter randomized clinical trial

Study on the safety of opioid-free anesthesia in elderly patients during gastrointestinal endoscopy:a prospective multicenter randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078384
Enrollment
Unknown
Registered
2023-12-07
Start date
2023-11-25
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Study on anesthesia plan during gastroscopy in the elderly

Interventions

PS Group:Propofol (1.0-1.5mg/kg)+sufentanil (0.5µg/kg)
RE Group:Remimazolam (0.2-0.3mg/kg)+Esketamine (0.2mg/kg)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Elderly patients (aged 60-80) who plan to undergo painless gastroscopy for diagnosis and treatment, regardless of gender. 2) The subjects clearly understand and voluntarily participate in this study. 3) The informed consent form shall be signed by the subjects themselves and they shall voluntarily comply with the research process 4) ASA level I-II.

Exclusion criteria

Exclusion criteria: 1) According to the evaluation of the researchers, respiratory and/or pulmonary diseases that are not suitable for participation in the study include those who are expected to have difficulty intubating and those who suffer from sleep apnea syndrome; Patients with potentially life-threatening circulatory and respiratory diseases that have not been fully controlled. 2) Subjects who received general anesthesia within the first 7 days of randomization and those who received emergency treatment; 3) Have a history of tachycardia and/or severe arrhythmia; Patients with previous severe angina attacks, unstable angina or myocardial infarction in the past six months 4) Individuals with mental system disorders (such as schizophrenia, depression, etc.) and cognitive impairment; Having a history of epilepsy; Previous history of abuse of psychotropic and anesthetic drugs; Intracranial hypertension; 5) Hypertensive and hypotensive subjects who have not received formal antihypertensive treatment or have poor blood pressure control (screening period sitting systolic blood pressure = 180mmHg or = 90mmHg, and/or screening period diastolic blood pressure = 100mmHg or = 60mmHg); 6) People with severe liver and kidney dysfunction and poor control of diabetes 7) Clearly identify individuals who are allergic to the research medication.

Design outcomes

Primary

MeasureTime frame
hypotension;

Secondary

MeasureTime frame
hypoxemia;hypertension;polycardia;bradycardia;

Countries

China

Contacts

Public ContactWang Xiao

West China Hospital, Sichuan University

1490829116@qq.com+86 189 8060 1549

Outcome results

None listed

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