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A double-blind controlled study of remimazolam besylate versus propofol combined with alfentanil in patients undergoing painless colorectal polypectomy

A double-blind controlled study of remimazolam besylate versus propofol combined with alfentanil in patients undergoing painless colorectal polypectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125283
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Intestinal polyp

Interventions

Remimazolam group:During the induction period, intravenous injection of alfentanil 7 µg/kg should be administered, pushed over more than 10 seconds. After 30 seconds, slowly inject remimazolam besylat
Propofol group:During the induction period, administer a slow intravenous injection of alfentanil at 7 µg/kg, pushing over more than 10 seconds. After 30 seconds, slowly inject propofol injection intr
additionally, give propofol at 0.2 mg/kg (push over 10 seconds) every 10 minutes or when the patient shows movements during surgery or noticeable swallowing actions, until stabilization is achieved. T

Sponsors

Longquanyi District First People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective painless colorectal polypectomy; 2. Aged 18 to 60 years, any gender; 3. Body Mass Index (BMI): 18–28 kg/m²; 4. American Society of Anesthesiologists (ASA) Physical Status Classification: I–III;

Exclusion criteria

Exclusion criteria: 1. Subjects who explicitly refuse to participate in this study; 2. Patients with abnormal liver or kidney function; 3. Those allergic to opioids, benzodiazepines, propofol, flumazenil, or naloxone excipients; 4. Use of ß-blockers, anti-anxiety drugs, or antidepressants; 5. Electrocardiogram indicating: heart rate 100 beats/min, or severe arrhythmia; 6. History of acute respiratory infection within 1 week that has not been cured; 7. History of severe heart, brain, lung, liver, kidney, or metabolic diseases, neuromuscular system diseases (e.g., myasthenia gravis), or psychiatric disorders; 8. Preoperative hypertension with systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, or hypotension < 90/60 mmHg; 9. Other subjects whom the researchers deem unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
SPO2;Mean arterial pressure;

Countries

China

Contacts

Public ContactQiang Zhang

Longquanyi District First People's Hospital)

429398454@qq.com

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026