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Sequential determination of the effective dose of ciprofol for inhibiting gastroscopic insertion responses in adult patients of different ages when combined with oxiracetam

Sequential determination of the effective dose of ciprofol for inhibiting gastroscopic insertion responses in adult patients of different ages when combined with oxiracetam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117846
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-03-01
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

Gastroscope insertion reaction

Interventions

Young adult group (18-44 years):All patients received oliceridine at a fixed dose of 0.02 mg/kg, with an initial dose of ciprofol set at 0.4 mg/kg. The ciprofol dose for subsequent enrolled patients w
conversely, the ciprofol dose for the next patient was increased by one dose gradient. One dose gradient of ciprofol for the young adult group was defined as 0.04 mg/kg.
Middle-aged adult group (45-64 years):All patients received oliceridine at a fixed dose of 0.02 mg/kg, with an initial dose of ciprofol set at 0.4 mg/kg. The ciprofol dose for subsequent enrolled pati
conversely, the ciprofol dose for the next patient was increased by one dose gradient. One dose gradient of ciprofol for the middle-aged adult group was defined as 0.04 mg/kg.
Elderly group (=65 years):All patients received oliceridine at a fixed dose of 0.02 mg/kg, with an initial dose of ciprofol set at 0.3 mg/kg. The ciprofol dose for subsequent enrolled patients was det
conversely, the ciprofol dose for the next patient was increased by one dose gradient. One dose gradient of ciprofol for the elderly group was defined as 0.03 mg/kg.

Sponsors

Bo'ai Hospital of Zhongshan City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-85 years old: Youth group 18- 44 years old, Middle-aged group 45-64 years old, Senior group >=65 years old, gender not limited. 2. Scheduled painless gastroscopy is planned, with ASA grade I to III (excluding high-risk groups such as severe cardiopulmonary insufficiency and liver and kidney failure). 3. Weight: 40-90 kg, BMI: 18.5-24.9 kg/m ² 4. Understand the research content and voluntarily sign the informed consent form, and be able to cooperate with postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Allergic to oxelidine, cyclopofol or opioid drugs; 2. Severe airway malformations/difficult airways and respiratory dysfunction (such as acute exacerbation of COPD, sleep apnea syndrome); 3. Severe liver and kidney dysfunction (Child-Pugh grade C or eGFR < 30 ml/min); 4. There has been a history of opioid abuse or long-term use of sedative and analgesic drugs within the past 3 months; 5. Mental illness or cognitive impairment makes it impossible to cooperate with monitoring; 6. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
The ED50 of ciprofol combined with oliceridine for inhibiting gastroscopic insertion response in adult patients of three age groups;

Secondary

MeasureTime frame
Vital signs(HR/MAP/SPO2);Safety indicators (including: bradycardia, tachycardia, respiratory depression (SpO2 10 seconds), hypotension, nausea and vomiting, chills, delayed awakening, delirium);Narcotrend Index (NTI);Awakening time;Patient satisfaction score;Duration of gastroscopy;The time for achieving success through induction;The additional dose and total dosage of ciporophene;

Countries

China

Contacts

Public ContactDeng Lizhen

Bo'ai Hospital of Zhongshan City

denglz2010@163.com+86 159 7606 1066

Outcome results

None listed

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