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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →DongGuk University is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Ran from Aug 2023 to primary completion in May 2025, 21 months.
Of 23 phase 4 interventional studies under Respiratory Insufficiency, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 21 months is above that.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drugs tested here: Propofol · Remimazolam
DongGuk University