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The Median Effective Dose and studies on Pharmacokinetics of Afentanil combined with Remimazolam Tosilate for hysteroscopic Surgery

The Median Effective Dose and studies on Pharmacokinetics of Afentanil combined with Remimazolam Tosilate for hysteroscopic Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097312
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

The Median Effective Dose and studies on Pharmacokinetics of Afentanil combined with Remimazolam Tosilate for hysteroscopic Surgery

Interventions

Patients undergoing hysteroscopic surgery:If the patient has a reaction such as body movement affecting the examination operation during the hysteroscopic diagnosis and treatment operation, and each b

Sponsors

Qingdao Women and Children's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Operation time < 30min; b) Patients who can tolerate anesthesia and hysteroscopy; c) ASA grades I ~ II; d) Age 20-60 years old; e) body mass index (BMI) 18-25 kg/m^2; f) No recent use of benzodiazepines, opioids, no history of narcotic drug dependence; g) Before the trial, patients should have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, understand the study procedure and sign the informed consent in person.

Exclusion criteria

Exclusion criteria: a) Patients with severe heart, brain, lung, kidney and other vital organ dysfunction; b) Patients with neurological diseases, cognitive dysfunction and mental disorders; c) Allergic to benzodiazepines, opioids, propofol and other drugs used in this study; d) Patients with recent acute respiratory inflammation and no cure history; e) Long-term use of analgesic and sedative drugs, suspected drug abuse, narcotic sedative and analgesic drugs; f) Preoperative BBP > 180mmHg and/or diastolic blood pressure > 110mmHg.

Design outcomes

Primary

MeasureTime frame
Intraoperative body movements;

Secondary

MeasureTime frame
Changes in heart rate, mean arterial pressure, oxygen saturation, respiratory rate;Time to induction of anesthesia;Duration of surgery;Anesthesia recovery time;Occurrence of adverse reactions;Pain 30 minutes after surgery;Postoperative nausea and vomiting;Postoperative patient satisfaction;General condition of the patient;

Countries

China

Contacts

Public ContactLiang Yongxin

Department of Anesthesiology, Qingdao Women and Children's hospital

liangzi66@hotmail.com+86 138 0896 4009

Outcome results

None listed

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