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Study on the Effectiveness and Safety of Ciprofol for Opioid-free Anesthesia in Painless Gastrointestinal Endoscopy

Study on the Effectiveness and Safety of Ciprofol for Opioid-free Anesthesia in Painless Gastrointestinal Endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082658
Enrollment
Unknown
Registered
2024-04-03
Start date
2024-04-03
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Painless Gastrointestinal Endoscopy

Interventions

Ciprofol group:The initial intravenous dose of Ciprofol is 0.6mg/kg, and the injection time is 30 seconds.
Ciprofol+Sufentanil group:Sufentanil was administered intravenously at 0.1µg/kg, and then 0.4mg/kg Ciprofol was slowly injected 1min later for 30s.
Ciprofol+Esketamine group:Esketamine was administered intravenously at 0.2mg/kg, and then 0.4mg/kg Ciprofol was slowly injected 1min later for 30s.

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age = 18 years old, = 75 years old, gender unlimited 2.Patients receiving conventional painless gastroscopy combined with colonoscopy for diagnosis and treatment 3.ASA rated as Level I or II 4.18kg/m2=BMI=30kg/m2 5.Expected gastroscopy operation time does not exceed 30 minutes 6.Clearly understand and voluntarily participate in the study, and have their informed consent form signed by themselves or their family members

Exclusion criteria

Exclusion criteria: 1.Complex endoscopic diagnosis and treatment techniques are required, with an estimated gastrointestinal endoscopy operation time exceeding 30 minutes 2.Long term use of opioid drugs 3.Patients planning to undergo tracheal intubation 4.After entering the room, the patient's SpO2 = 95% 5.Diagnosed as sleep apnea syndrome 6.Has serious heart disease 7.Systolic blood pressure = 180mmHg or/and diastolic blood pressure = 110mmHg 8.History of respiratory dysfunction and obstructive pulmonary disease 9.There is a history of uncontrolled diseases with significant clinical significance, such as liver, kidney, blood system, nervous system, or metabolic system, that researchers have determined may not be suitable for participation in the study 10.Pregnant or lactating women 11.Known allergies to eggs, soy products, opioid drugs and their antidotes, propofol, etc 12.Participated in other drug clinical trials as a subject within 3 months 13.Have a history of alcoholism within 3 months 14.Individuals with a history of traumatic brain injury, possible seizures, myoclonus, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; Patients with schizophrenia, intellectual disabilities, mania, mental disorders, long-term use of psychotropic drugs, drug addiction, and a history of cognitive impairment 15.Researchers believe that patients should not participate in this trial

Design outcomes

Primary

MeasureTime frame
Sedation success rate;Overall incidence of adverse events;

Secondary

MeasureTime frame
Wake-up time;

Countries

China

Contacts

Public ContactWeijian Wang

The First Affiliated Hospital of Wenzhou Medical University

wangwj2002@163.com+86 138 0668 3232

Outcome results

None listed

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