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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065013
Enrollment
Unknown
Registered
2022-10-25
Start date
2022-10-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Painless gastroenteroscopy

Interventions

Alfentanil plus propofol group (AP group):Alfentanil 7 µg/kg, propofol 2 mg/kg
Alfentanil combined with Remazolam besylate group (AR group):Alfentanil 7 µg/kg, remazolam besylate 0.2 mg/kg
Sufentanil plus Remazolam besylate group (SR group):Sufentanil 0.1 µg/kg, remazolam besylate 0.2 mg/kg

Sponsors

People’s Hospital of Lishui
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who met all of the following criteria were considered for enrollment: 1) Patients undergoing elective painless gastroscopy and colonoscopy; 2) Age 18-60, both sexes; 3) Body mass index (BMI): 18.5-28 kg/m2; 4) American Society of Anesthesiologists Classification (ASA): I~II; 5) Operation time within 45 min; 6)Subjects voluntarily participated in the study and signed the informed consent form for the study.

Exclusion criteria

Exclusion criteria: Patients who met any of the following criteria were not eligible for inclusion: 1) The subject explicitly refuses to participate in this study; 2) Allergic to opioids, benzodiazepines, propofol, flumazenil or naloxone excipients; 3) Use of beta-blockers, anti-anxiety drugs and antidepressants; 4) Suspected abuse of narcotic analgesics or sedatives, as well as alcoholics; 5) Electrocardiogram prompts: heart rate 100 beats /min or severe arrhythmia; 6) A history of acute respiratory tract infection within 2 weeks without cure; 7) Patients with a history of severe heart, brain, lung, liver, kidney or metabolic diseases, neuromuscular system diseases (such as myasthenia gravis), mental diseases; 8) Preoperative systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg in hypertensive patients, or <90/60 mmHg in hypotensive patients; 9) Patients with previous history of gastrointestinal diversion; 10) Patients with previous abnormal surgical anesthesia recovery history; 11) Those who are predicted to have or have had difficult airway, such as modified Mahalanobis grade III-IV; 12) Pregnant or lactating women and patients (including men) who plan to have children within 3 months 13) Other subjects deemed inappropriate by other investigators to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative respiratory depression;

Secondary

MeasureTime frame
effectiveness index;safety index;Satisfaction score;

Countries

China

Contacts

Public ContactJimin WU

People’s Hospital of Lishui

wujimin2022@163.com18957091906

Outcome results

None listed

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