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Comparison of the efficacy and safety of equivalent doses of ciprofol versus propofol in elderly patients undergoing gastroscopy.

Comparison of the efficacy and safety of equivalent doses of ciprofol versus propofol in elderly patients undergoing gastroscopy.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117482
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Anesthesia/Sedation Management in Geriatric Patients Undergoing Gastrointestinal Endoscopy

Interventions

Ciprofol Sequential Design Group:Based on preliminary experiments and relevant literature, the initial dose of ciprofol in Group C1 was set at 0.3 mg/kg, with a dose gradient of 0.02 mg/kg. The formal
conversely, it was decreased by one dose gradient. This process was repeated until the eighth crossover inflection point was observed, at which point the trial was terminated.
Propofol Sequential Design Group:Based on preliminary experiments and relevant literature, the initial dose of propofol in Group P1 was set at 1.5 mg/kg, with a dose gradient of 0.1 mg/kg. The formal
The Ciprofol Group:Following nasopharyngeal oxygen insufflation, alfentanil (7 µg/kg) was administered intravenously over a period of at least 30 seconds, but within 60 seconds. Subsequently, patients

Sponsors

Liaoning Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective gastroscopy; 2.Aged >=65 years; any sex; 3.ASA physical status classification I–II; 4.Cardiac function class I–II (NYHA classification implied); 5.BMI 18–28 kg/m²; 6.Signed informed consent form obtained from patient;

Exclusion criteria

Exclusion criteria: 1.Known allergy or contraindication to anesthetic drugs (e.g., ciprofol, opioids), egg products, soy, or related pharmaceuticals; 2.Neurological disorders (including: traumatic brain injury, seizure disorders, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; schizophrenia, mania, psychosis, chronic psychotropic medication use, impaired consciousness, cognitive dysfunction) OR opioid/sedative use within 1 week; 3.History of alcohol abuse (>2 standard drinks/day in past 3 months; 1 drink=14g alcohol: 360mL beer/45mL 40% spirits/150mL wine) OR substance use disorder (opioids/sedative-hypnotics); 4.Pregnant or lactating women; 5.Anticipated difficult airway or need for intubation (including laryngeal mask): (a) Asthma/wheezing history (b) Sleep apnea syndrome (c) Personal/family history of malignant hyperthermia (d) Previous failed intubation (e) Clinically assessed difficult airway (Modified Mallampati Score IV); 6.General anesthesia contraindications or prior anesthesia accidents; 7.Significant organ dysfunction/comorbidities: (a) Cardiovascular: Uncontrolled hypertension (SBP>=170mmHg or DBP>=105mmHg untreated; >160/>100mmHg on treatment), severe cardiac disease, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction (=450ms (b) Respiratory: Respiratory insufficiency, aspiration pneumonitis, bronchospasm requiring treatment (<=3 months), active respiratory infection with fever/dyspnea/cough (<=1 week); 8.Contraindications to routine endoscopy;

Design outcomes

Primary

MeasureTime frame
Mean Arterial Pressure ;Heart Rate;Oxygen Saturation;Respiratory Rate;hypotension;respiratory depression;bradycardia;tachycardia;nausea;vomiting;hiccups;pain during intravenous injection;intraoperative awareness;postoperative delirium;

Secondary

MeasureTime frame
success rate of sedation;time to full awakening;time to loss of consciousness;time to discharge readiness;satisfaction levels of the patient, endoscopist, and anesthesiologist;

Countries

China

Contacts

Public ContactLI Songze,Liu Zihe

Liaoning Cancer Hospital & Institute

lisongze999@163.com+86 180 4139 4511

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026