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A multicenter, prospective, randomized, double-blind, controlled study of the efficacy and safety of afentanil hydrochloride combined with remazolam besylate for painless gastroscopy and colonoscopy clinical trial protocol

A multicenter, prospective, randomized, doulbe-blind, controlled study of the efficacy and safety of afentanil hydrochloride combined with remazolam besylate for painless gastroscopy and colonoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084819
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

pain

Interventions

Afentanil combined with propofol group (AP group):During the induction period, 7 µg/kg of Afentanil was slowly injected intravenously and pushed for more than 10 s. After 30 s, propofol 2 mg/kg was in
Afentanil combined with Remazolam benzoate group (AR group):During the induction period, 7 µg/kg of Afentanil was injected intravenously and pushed for more than 10 s. After 30 s, 0.2 mg/kg of remazol
Sufentanil combined with Remazolam benzoate Group (SR group):During the induction period, Sufentanil was slowly injected intravenously with 0.1 µg/kg, and then pushed for more than 10 s. After 1-3 min
Sufentanil combined with propofol group (SP group):During the induction period, Sufentanil was slowly injected intravenously with 0.1 µg/kg and pushed for more than 10 s. Propofol was injected intrave

Sponsors

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing elective painless gastroscopy and colonoscopy; 2) Age 18-65 years old, gender is not limited; 3) Body Mass Index (BMI) : 18.5~28 kg/m2; 4) American Society of Anesthesiologists (ASA) Grade I to II; 5) Operation time within 45 min; 6) The subjects voluntarily participate in the experiment and sign the informed consent of the experiment.

Exclusion criteria

Exclusion criteria: 1) The subject explicitly refuses to participate in the study; 2) Patients with a history of allergy to opioids, benzodiazepines, propofol, flumazenil or naloxone; 3) Use beta blockers, anti-anxiety drugs, antidepressants; 4) Suspected abuse of narcotic analgesics or sedatives, and alcohol abuse; 5) Electrocardiogram: heart rate 100 times /min or severe arrhythmia; 6) A history of acute respiratory infection within 2 weeks with no cure; 7) Have a history of serious heart, brain, lung, liver, kidney or metabolic diseases, neuromuscular system diseases (such as myasthenia gravis), mental illness; 8) Preoperative systolic blood pressure of hypertensive patients > 180 mmHg and/or diastolic blood pressure > 110 mmHg, or patients with low blood pressure < 90/60 mmHg; 9) Patients with a history of gastrointestinal tract change; 10) Patients with a history of recovery from abnormal surgical anesthesia; 11) Predict those who may develop or have developed difficult airway, such as modified Markov scale ?-?; 12) Pregnant or lactating women and patients (including men) who plan to have a baby within 3 months 13) Other subjects whom the investigator considers inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Ramsay rating;

Secondary

MeasureTime frame
Heart rate;Blood pressure;Oxygen saturation;respiratory rate;MOAA/S score;Subject satisfaction;VAS score;

Countries

China

Contacts

Public ContactRen Yingbo

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

124866127@qq.com+86 181 1357 8572

Outcome results

None listed

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