A Phase 4 interventional study of Propofol and Remimazolam in Propofol, Remimazolam and Hysteroscopic Surgery, sponsored by DongGuk University. Completed at 1 site in South Korea. Open to female participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by DongGuk University · Phase 4, Interventional, and Supportive care
The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery
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.
Exclusion Criteria:
Propofol infusion with remifentanil for hysteroscopic surgery
Drug: Propofol
Remimazolam infusion with remifentanil for hysteroscopic surgery
Drug: Remimazolam
Propofol infusion with remifentanil
Remimazolam infusion with remifentanil
Respiratory insufficiency before surgery
Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%
Time frame: From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)
Respiratory insufficiency during surgery
Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%
Time frame: From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes)
Pain on injection
Patients will answer just after drug infusion begins (Yes or No)
Time frame: Just after the beginning of drug infusion
Hypertension
\> 140 mmHg during Monitored Anesthetic Care (MAC)
Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes
Hypotension
\< 90 mmHg during the Monitored Anesthetic Care
Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes
Bradycardia
Heart rate \< 50/min during the Monitored Anesthetic Care
Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes
Tachycardia
Heart rate \> 100/min during the Monitored Anesthetic Care
Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes
Maximum ETCO2
ETCO2 will be measured every single respiration in the nasal cavity
Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes
Patient satisfaction with Monitored Anesthetic Care
4-point rating scale on the Satisfaction with MAC (4: Fully satisfied, 3: Partially satisfied, 2: Partially unsatisfied, 1: Totally unsatisfied)
Time frame: Just before leaving the recovery room
Postoperative Nausea/Vomiting (PONV)
Patients are asked to answer yes/no on PONV, just before leaving the recovery room.
Time frame: During staying at the recovery room (up to 60 minutes)
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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DongGuk University