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The influence of alfentanil versus remifentanil combined with propofol or remimazolam on the incidence of hypoxemia during painless colonoscopy: A multicenter, prospective, 2×2 factorial design, randomized controlled study

The influence of alfentanil versus remifentanil combined with propofol or remimazolam on the incidence of hypoxemia during painless colonoscopy: A multicenter, prospective, 2×2 factorial design, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102442
Enrollment
Unknown
Registered
2025-05-14
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Hypoxemia

Interventions

RF+RM:Rifentanil combined with remimazolam anesthesia.
AF+RM:The anesthesia protocol involves a combination of alfentanil and remimazolam.
AF+PR:A combination of Alfentanil and Propofol anesthesia.
RF+PR:Rifentanil combined with propofol anesthesia

Sponsors

Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 - 65 years old; 2.Patients undergoing elective painless colonoscopy examination; 3.ASA classification 1-2 grade; 4.Agree to participate in this research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in this study; 2. ASA III. or above; 3. BMI29.9kg/m^2; 4. History of chronic analgesic or sedative drug use, including benzodiazepines, alcohol abuse, allergy to propofol and remimazolam; 5. Electrocardiogram (ECG) suggests: heart rate 100 beats/min, or severe arrhythmia; 6. Those with a history of gastrointestinal diversion; 7. Cerebrovascular accident, myocardial infarction or unstable angina pectoris within the past 3 months; Severe liver and kidney dysfunction; Preoperative blood pressure >=180mmHg; 8. Participation in other research studies within the last 30 days; 9. Those who have a history of abnormal surgical anesthesia recovery in the past; 10. Those who predict that difficult airways may occur or have occurred, such as modified Mahalanobis class III.-IV;

Design outcomes

Primary

MeasureTime frame
The incidence of hypoxemia;

Secondary

MeasureTime frame
Success rate of colonoscopy;Non-interventional inspection time;Incidence of body movement;Incidence OF RESCUE SEDATION;Changes in respiratory rate;Incidence of injection pain;Patient comfort and endoscopist satisfaction scores;Incidence of cough;Incidence of nausea and vomiting;Narcotic drug consumption;

Countries

China

Contacts

Public ContactGu Xiaoping

Drum Tower Hospital

xiaopinggu@nju.edu.cn+86 25 83106666

Outcome results

None listed

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