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Effect of Alfentanil on the Pharyngeal Reflex in Patients Undergoing Gastrointestinal Endoscopy under Sedation: A Prospective Randomized Controlled Trial

Effect of Alfentanil on the Pharyngeal Reflex in Patients Undergoing Gastrointestinal Endoscopy under Sedation: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120164
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Digestive System Diseases

Interventions

Control group (Ciprofol and Remimazolam only):For the control group patients, they were first given an equal amount of normal saline, then 0.08 - 0.1 mg/kg remifentanil was administered, followed by 0
Experimental group (cyclopropofol, remimazolam and alfentanil):All patients in the experimental group were first given a 3 µg/kg intravenous injection of alfentanil, then 0.08 - 0.1 mg/kg remifentanil

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A total of 504 patients who underwent painless gastroscopy or painless gastroscopy combined with painless colonoscopy at the Gastrointestinal Endoscopy Center of the Second Xiangya Hospital, Central South University, from March 2026 to March 2027 were enrolled. The patients were classified as ASA grades I to III, aged between 18 and 64 years, with a MET score>= 3, and a BMI between 18 kg/m^2 and < 28 kg/m^2.

Exclusion criteria

Exclusion criteria: Exclusion criteria included: patients with ASA grade IV or above; severe tooth looseness; patients with very severe obstructive ventilatory dysfunction; those with anemia or thrombocytopenia; patients with pre-anesthesia pulse oxygen saturation (SpO2) < 94%; patients with severe liver or kidney dysfunction; pregnant or lactating patients; those with allergies or contraindications to benzodiazepines, ciprofol, or alfentanil; patients who had participated in other drug clinical trials within the previous 3 months; or any other conditions the investigators deemed unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Cough;

Secondary

MeasureTime frame
Compare the effects of the two groups of sedation protocols on the safety of respiration and circulation, including the incidence and handling requirements of sedation-related adverse events such as hypoxemia, respiratory depression, and hypotension, and evaluate their clinical applicability.;Compare the sedation quality indicators of the two groups of schemes, including the incidence of body movement and the ratio of additional sedation/medication for rescue.;

Countries

China

Contacts

Public ContactRuyi Luo

The Second Xiangya Hospital of Central South University

luoruyi@csu.edu.cn+86 731 8529 5970

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026