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Randomized controlled clinical study on the efficacy and safety of ciprofol for painless gastrointestinal endoscopy in children

Randomized controlled clinical study on the efficacy and safety of ciprofol for painless gastrointestinal endoscopy in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094669
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Painless diagnosis and treatment of pediatric gastrointestinal endoscopy

Interventions

one:Ciprofol group( Group C): After infusing 10µg/kg of afentanil, 0.4/0.2 mg/kg of ciprofol injection was administered through intravenous.That means the first dose is 0.4 mg/kg. The injection was m
two:Propofol group (Group P): After infusing 10µg/kg of afentanil, 2/1mg/kg of propofol was given.That means the first dose is 2mg/kg. The patients reaction was observed manually for 30 seconds, until

Sponsors

Hunan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 3 to 14 years old, regardless of gender; (2) American anesthesiologist classification (ASA) I-II; (3) Patients who choose to undergo painless gastroscopy and/or colonoscopy for diagnosis and treatment; (4) Body mass index (BMI) = 18 and = 30kg/m2; (5) Vital signs: respiratory rate = 10 and = 30 times/minute; Blood oxygen saturation (SpO2) = 95% when breathing air; Systolic blood pressure (SBP) = 80mmHg and = 140mmHg; Diastolic blood pressure (DBP) = 40mmHg and = 90mmHg; Heart rate = 55 and = 120 beats per minute; (6) The guardian understands the process and methods of this study and voluntarily participates in it.

Exclusion criteria

Exclusion criteria: (1) Individuals with contraindications to general anesthesia or a history of anesthesia accidents in the past (2) Individuals who are known or suspected to have allergies or contraindications to propofol, excipients for propofol injection, or opioid drugs (3) Patients with acute upper respiratory tract infections, asthma attacks, or airway obstruction (4) Gastrointestinal retention, active bleeding, possible reflux and aspiration, etc (5) Dysfunction of important organs such as heart, brain, liver, and kidney (6) Researchers believe that subjects with any other unfavorable factors to participate in this trial

Design outcomes

Primary

MeasureTime frame
Success rate of Gastrointestinal endoscopy ;

Secondary

MeasureTime frame
Time of Successful Anesthetic Induction;

Countries

China

Contacts

Public ContactShili Zhu

Hunan Children's Hospital

445437884@qq.com+86 136 0748 9215

Outcome results

None listed

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