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The efficacy and safety of alfentanil for patients undergoing colonoscopy: a multicenter randomized controlled study

The efficacy and safety of alfentanil for patients undergoing colonoscopy: a multicenter randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046314
Enrollment
Unknown
Registered
2021-05-13
Start date
2021-05-07
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

colonoscopy

Interventions

control group :sufentail 0.1µg/kg
experimental group 1:alfentanil 5µg/kg
experimental group 2:alfentanil 7.5µg/kg
experimental group 3:alfentanil 10µg/kg

Sponsors

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years, regardless of gender; 2.ASA I or II level; 3.Outpatients or inpatients undergoing elective painless colonoscopy or treatment; 4.The inspection time should be within 30 minutes (the inspection time is uniformly set as the time from the insertion of the colonoscope to the removal of the colonoscope); 5.Volunteer to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.People with chronic pain who have long-term use of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, and antidepressants), alcohol abusers; 2.BMI > 30 kg/m2; 3.Abnormal liver and kidney function before surgery; 4.Preoperative hypertensive patients with systolic blood pressure > 180mmHg and/or diastolic blood pressure > 110mmHg, or patients with hypotension (blood pressure < 90/60mmHg); 5.Have a history of abnormal surgical anesthesia recovery; 6.Suffer from esophageal reflux disease; 7.Sedative or analgesic drugs were used 24 hours before the operation; 8.History of allergy to propofol, soy, glycerin or opioids; 9.Subjects with chronic lung disease; 10.Pregnant or parturient; 11.Suspected patients with difficult airways; 12.Participated in other drug trials within three months.

Design outcomes

Primary

MeasureTime frame
recovery time;discharge time;

Secondary

MeasureTime frame
directed force recovery time;

Countries

China

Contacts

Public ContactWang Sheng

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

18935701573@163.com+86 18935701573

Outcome results

None listed

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