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PropofolPhase 4NCT07076628

Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

A Phase 4 study testing Propofol and Remimazolam in people with Propofol and Remimazolam, run by DongGuk University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery Read more about this study

Who is it for?
Ages 19 to 60 years, women only
Conditions the study is for
Propofol, Remimazolam, Hysteroscopic Surgery
What is being tested?
Propofol and Remimazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSouth Korea
Study dates
24 Aug 2023to 30 May 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • ASA PS 1-2
  • Elective hysteroscopic surgery under monitored anesthesia care
  • No drug abuse history

Who cannot join

  • BMI > 30 kg/m2
  • Hepatic or renal insufficiency
  • Alcohol abuse
  • Respiratory, hemodynamic compromise, or diseases
  • History of general/regional anesthesia during the last month
  • A patient who is taking sedatives or analgesics
  • Under the investigator's judgment

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

    Goyang, Gyeonggido, 10326

Other trials in South Korea

About this study

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

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

Read the 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.
Being tested
Propofol, Remimazolam
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Propofol infusion with remifentanil

  • RemimazolamDrug

    Remimazolam infusion with remifentanil

Study groups in NCT07076628
Study groupRoleWhat they receive
Propofol groupActive comparatorPropofol infusion with remifentanil for hysteroscopic surgery
Receives: Drug: Propofol
Remimazolam groupActive comparatorRemimazolam infusion with remifentanil for hysteroscopic surgery
Receives: Drug: Remimazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory insufficiency before surgery

    Respiratory rate < 9/min, Apnea > 29 s, ETCO2 > 54 mmHg, SpO2 < 96%

    Measured: From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)

  2. Respiratory insufficiency during surgery

    Respiratory rate < 9/min, Apnea > 29 s, ETCO2 > 54 mmHg, SpO2 < 96%

    Measured: From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes)

Secondary outcomes (8)

  1. Pain on injection

    Patients will answer just after drug infusion begins (Yes or No)

    Measured: Just after the beginning of drug infusion

  2. Hypertension

    > 140 mmHg during Monitored Anesthetic Care (MAC)

    Measured: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

  3. Hypotension

    < 90 mmHg during the Monitored Anesthetic Care

    Measured: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

  4. Bradycardia

    Heart rate < 50/min during the Monitored Anesthetic Care

    Measured: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

  5. Tachycardia

    Heart rate > 100/min during the Monitored Anesthetic Care

    Measured: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

  6. Maximum ETCO2

    ETCO2 will be measured every single respiration in the nasal cavity

    Measured: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

  7. 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)

    Measured: Just before leaving the recovery room

  8. Postoperative Nausea/Vomiting (PONV)

    Patients are asked to answer yes/no on PONV, just before leaving the recovery room.

    Measured: During staying at the recovery room (up to 60 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start24 Aug 2023
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be enrolled to one of the two drug groups with randomization.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076628
Sponsor's protocol ID
J In 2021-1
Status last verified
Jul 2025
First submitted
2 Feb 2022
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang X, Li S, Liu J. Correction to: Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial. BMC Anesthesiol. 2021 Jun 18;21(1):173. doi: 10.1186/s12871-021-01390-x. No abstract available.

    PubMed 34144683

  • Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.

    PubMed 22190555

  • Wiltshire HR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part II. Population pharmacokinetic and pharmacodynamic modeling and simulation. Anesth Analg. 2012 Aug;115(2):284-96. doi: 10.1213/ANE.0b013e318241f68a. Epub 2012 Jan 16.

    PubMed 22253270

  • Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877.

    PubMed 32530890

  • Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16.

    PubMed 32417976

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Remimazolam in people with Propofol and Remimazolam, run by DongGuk University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory insufficiency before surgery (time frame: From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076628, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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