NCT07076628

Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

Incidence of Respiratory Depression of Remimazolam Compared With Propofol for Monitored Anesthesia Care During Hysteroscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: DongGuk University · Academic / Other
• Sex: Female
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery

Detailed description

* Non-invasive blood pressure, electrocardiogram, and oxygen saturation sensors are attached. * Wear an oxygen mask (5L per minute), and place the sampling line for end-tidal carbon dioxide partial pressure measurement inside the nose. * Check the randomization table to determine the drug to be administered, and prepare propofol or remimazolam accordingly. * Record the baseline values (0 min). * Start administration of Remifentanil. ⑥ Administer anesthesia to adjust the maintenance dose to reach a sedation level of 2 or less on the MOAA/S scale. ⑦ Adjust the remifentanil dose according to the patient's response ⑧ When the target sedation level is reached, the surgical preparation process and surgery begin, and the study variables are observed and recorded at 5-minute intervals. ⑨ Stop drug administration upon end of surgery. ⑩ After confirming proper recovery of consciousness and spontaneous breathing, leave the recovery room. ⑪ Before leaving the recovery room, check the complete recovery and investigate the patient's satisfaction with anesthesia.

Conditions

• Propofol
• Remimazolam
• Hysteroscopic Surgery
• Respiratory Insufficiency
• Hemodynamics Instability

Interventions

Type	Name	Description
DRUG	Propofol	Propofol infusion with remifentanil
DRUG	Remimazolam	Remimazolam infusion with remifentanil

Timeline

• Start date: 2023-08-24
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: South Korea