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A multicenter randomized double-blind controlled trial of remazolam besylate combined with sufentanil in patients with painless colonoscopy

A multicenter randomized double-blind controlled trial of remazolam besylate combined with sufentanil in patients with painless colonoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048729
Enrollment
Unknown
Registered
2021-07-13
Start date
2021-07-16
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

colonoscopy

Interventions

group R:Sufentanil 0.1 µg/kg intravenously, followed by intravenous injection of remazolam besylate 7 mg
group P:Sufentanil 0.1 µg/kg intravenously followed by propofol 1.5 mg/kg intravenously

Sponsors

Hangzhou Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old; 2. Patients undergoing elective painless colonoscopy; 3. American Society of Anesthesiologists (ASA): Class I-III; 4. Body mass index (BMI): 18.5-30 kg/m2; 5. The inspection time is within 30 minutes.

Exclusion criteria

Exclusion criteria: 1.The subject clearly refused to participate in this study; 2.Those with a history of serious heart, brain, lung, liver, kidney and metabolic diseases; 3.Those who have a history of abnormal surgical anesthesia recovery; 4.ECG prompt: heart rate 180 mmHg and (or) diastolic blood pressure >110 mmHg, or hypotension patients <90/60 mmHg; 7.Those with neuromuscular system disease or mental illness; 8.Suspected of abusing narcotic analgesics or sedatives; 9.Those who predict that a difficult airway may or have occurred; 10.Subjects deemed unsuitable to participate in this study by the researcher.

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxemia;

Secondary

MeasureTime frame
blood pressure;heart rate;Respiratory;Ramsay score;

Countries

China

Contacts

Public ContactTao Fan

Hangzhou Red Cross Hospital

765454165@qq.com+86 15867199018

Outcome results

None listed

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