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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043890
Enrollment
Unknown
Registered
2021-03-04
Start date
2021-05-20
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

Gastroscope, colonoscopy

Interventions

Alfentanil combined with propofol group (AP group):Alfentanil 7 µg/kg was injected intravenously during the induction period, and propofol 2 mg/kg was injected intravenously later
if the patient has physical movement or obvious swallowing movements during the operation, add propofol 0.5 mg/kg
Alfentanil combined with remazolam besylate group (AR group):Alfentanil 7 µg/kg was injected intravenously during the induction period, and remazolam besylate 0.2 mg/kg was injected intravenously late
if the patient has physical movement or obvious swallowing movements during the operation, add benzenesulfonic acid Remazolam 2.5 mg
Sufentanil combined with remazolam besylate group (SR group):Sufentanil 0.1 µg/kg was injected intravenously during the induction period, and remazolam besylate 0.2 mg/kg was injected intravenously la
if the patient exhibits physical movement or obvious swallowing movements during the operation, add benzenesulfonic acid Remazolam 2.5 mg

Sponsors

Xiang'an Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing elective painless gastric and colonoscopy; 2) Aged 18-60 years, no gender limit; 3) Body mass index (BMI): 18.5-28 kg/m2; 4) American Association of Anesthesiologists classification (ASA): I-II; 5) Operating time within 45 min; 6) Subjects voluntarily participate in the trial and sign the informed consent form for this trial.

Exclusion criteria

Exclusion criteria: 1) Those who are allergic to opioids, benzodiazepines, propofol, flumazenil or naloxone pharmaceutical excipients; 2) Use ß-blockers, anxiolytics, and antidepressants; 3) Suspected of abuse of narcotic analgesics or tranquilizers, and alcoholics; 4) ECG prompt: heart rate 100 beats/min, or severe arrhythmia; 5) Acute respiratory infections and uncured medical history within 2 weeks; 6) Those with a history of serious heart, brain, lung, liver, kidney or metabolic diseases, those with neuromuscular system diseases (such as myasthenia gravis), or mental illness; 7) Preoperative hypertension patients with systolic blood pressure > 180 mmHg and (or) diastolic blood pressure >110 mmHg, or hypotension patients < 90/60 mmHg; 8) Those who have a history of recovery from abnormal operation anesthesia; 9) It is predicted that difficult airways may occur or have occurred, such as modified Markov classification III-IV; 10) Pregnant or lactating women and patients who have a childbirth plan within 3 months (including men); 11) Other subjects considered unsuitable to participate in this study by other researchers.

Design outcomes

Primary

MeasureTime frame
Respiratory depression;

Secondary

MeasureTime frame
blood pressure;heart rate;SPO2;Ramsay score;

Countries

China

Contacts

Public ContactHou Lichao
45278436@QQ.COM+86 13891936309

Outcome results

None listed

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