Skip to content

Clinical study on the application of remimazolam combined with esketamine in hysteroscopic surgery

Clinical study on the application of remimazolam combined with esketamine in hysteroscopic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088162
Enrollment
Unknown
Registered
2024-08-13
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Patients undergoing hysteroscopic surgery under general anesthesia without intubation

Interventions

Experimental group (Part 1):Different dose of remimazolam combined with esketamine
Control group (Part 2):Propofol combined with esketamine
Experimental group (Part 2):Remimazolam tosilate combined with esketamine

Sponsors

Zhuji People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) perform hysteroscopic surgery under general anesthesia without intubation, 2) Aged 18-60 years old, 3) had no respiratory infection for at least a week,4) ASA I-III, 5) BMI 18-30 kg/m 2, 6) No difficult airway was expected before surgery.

Exclusion criteria

Exclusion criteria: 1) refused to participate in the study; 2) allergic or contraindication to benzodiazepines, propofol, esketamine or their components; 3) preoperative hepatic and renal dysfunction or other serious systemic diseases; 4) had a history of psychotropic drugs or sedative-hypnotic drugs use; 5) operation time exceeding 30 minutes or transfer to tracheal intubation

Design outcomes

Primary

MeasureTime frame
ED90 of remimazolam combined with esketamine (Part 1);Time from immediate induction to loss of consciousness (Part 2);

Secondary

MeasureTime frame
Total dose of remimazolam (Part 1);Time to fall asleep (Part 1);Postoperative VAS pain score (Part 2);Postoperative complications (Part 2);Postoperative depression (Part 2);Perioperative hemodynamics indicators (Part1 and 2);Perioperative adverse events (Part1 and 2);Anesthesia time, Operation Time, Recovery time (Part1 and 2);

Countries

China

Contacts

Public ContactHuang Xiaolin

Zhuji People's Hospital

316041928@qq.com+86 137 5858 0265

Outcome results

None listed

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