Efficacy and adverse reactions of Remimazolam Tosilate for Injection combined with Alfentanil in painless gastroscopy patients: a prospective, single center, randomized, controlled clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300077252

Enrollment

Unknown

Registered

2023-11-02

Start date

2023-11-02

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

gastrointestinal endoscopy

Interventions

Experimental group :Remimazolam Tosilate for Injection sedation

Control group:Propofol sedation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who plan to undergo gastroscopy examination; (2) American Society of Anesthesiologists (ASA) grading I to II; (3) Mallampati grading I to II; (4) Age 18-75 years old, regardless of gender; (5) Body mass index, BMI 18-30kg/m2; (6) Expected painless gastroscopy examination time<20min; (7) The patient or family member agrees to participate in this study and signs an informed consent form;

Exclusion criteria

Exclusion criteria: (1) The subject explicitly refused to participate in this study; (2) Having severe heart and lung diseases, or abnormal metabolic diseases of the liver and kidneys; (3) Patients with gastrointestinal obstruction or gastric motility disorders; (4) Having severe neurological disorders; (5) Suspected of abusing narcotic analgesics, sedatives, or long-term use of benzodiazepines; (6) Individuals who are allergic to emulsions, opioids, and benzodiazepines; (7) Painless gastroscopy examination time = 20 minutes; (8) Preoperative lateral supine systolic blood pressure (SBP) = 180mmHg and/or diastolic blood pressure (DBP) = 110mmHg;

Design outcomes

Primary

Measure	Time frame
Subjects' heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse oxygen saturation during the trial process;	—

Secondary

Measure	Time frame
Anesthesia onset time,Operating time,Awake time;The occurrence of various adverse events during the trial process of the subjects(Adverse reactions such as injection pain, hypoxemia, hypotension, bradycardia, intraoperative body movement, hiccup, postoperative nausea and vomiting, and the occurrence of drug supplementation times greater than 3 times);Physician and patient satisfaction scores(VAS);	—

Measure

Time frame

Anesthesia onset time,Operating time,Awake time;The occurrence of various adverse events during the trial process of the subjects(Adverse reactions such as injection pain, hypoxemia, hypotension, bradycardia, intraoperative body movement, hiccup, postoperative nausea and vomiting, and the occurrence of drug supplementation times greater than 3 times);Physician and patient satisfaction scores(VAS);

—

Countries

China

Contacts

Public ContactLeng Yufang

The First Hospital of Lanzhou University

lengyf@lzu.edu.cn+86 177 9317 5611

Outcome results

None listed

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