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A Study on the Efficacy and Safety of A Hydrochloride Combined with Ramazolone Benzenesulfonate for Painless Linear Ultrasonic Gastroscopy Examination: A Randomized Controlled Study

A Study on the Efficacy and Safety of A Hydrochloride Combined with Ramazolone Benzenesulfonate for Painless Linear Ultrasonic Gastroscopy Examination: A Randomized Controlled Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119078
Enrollment
Unknown
Registered
2026-02-14
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Intraoperative hypotension

Interventions

experimental group:During the operation, alfentanil combined with remimazolam was used for anesthesia and sedation.
control group:During the operation, alfentanil combined with propofol was used for anesthesia and sedation.

Sponsors

People's Hospital of Leshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients who undergo elective painless linear ultrasonic gastroscopy examination; 2.Age range: 18 - 80 years old. Gender: No restrictions. 3.Body Mass Index (BMI): 18.5 - 28 kg/m^2; 4.American Society of Anesthesiologists Classification (ASA): I - III grades; 5.The operation time is within 1 hour. 6.The subjects voluntarily participated in this trial and signed the informed consent form for this trial.

Exclusion criteria

Exclusion criteria: 1.The subjects explicitly refused to participate in this study. 2.Those with a previous history of allergic reactions to opioid drugs, benzodiazepines, propofol, flumazenil, or naloxone excipients; 3.Use beta-blockers, anti-anxiety drugs, and antidepressants; 4.Those suspected of abusing narcotic painkillers or sedatives, as well as alcoholics; 5.Electrocardiogram indication: Heart rate less than 50 beats per minute or more than 100 beats per minute, or presence of severe arrhythmia; 6.A history of acute respiratory infection within the past two weeks that has not been cured; 7.Those with a history of severe heart, brain, lung, liver, kidney or metabolic diseases, as well as those with neurological and muscular disorders (such as myasthenia gravis), or mental illnesses; 8.Patients with preoperative hypertension had a systolic blood pressure greater than 180 mmHg and/or a diastolic blood pressure greater than 110 mmHg, or patients with hypotension had a blood pressure lower than 90/60 mmHg. 9.Those who have a history of abnormal anesthesia recovery after previous surgeries; 10.Predict those who may or have had difficulty in breathing, such as those classified as grade ?-? according to the modified Mallory classification; 11.Pregnant or lactating women, as well as women with a planned pregnancy within the next 3 months; 12.Other researchers considered other participants who were not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Intraoperative hypotension;

Secondary

MeasureTime frame
The time from awakening to leaving the post-anesthesia care unit (PACU);awakening time;Physical movement;The proportion of successful operations;

Countries

China

Contacts

Public ContactLiang Jin

People's Hospital of Leshan

xzmzjl2828@163.com+86 833 211 9359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026