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Completed

NCT Number: NCT07076628

Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

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

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Key information

Conditions

Propofol Hemodynamics Instability Hysteroscopic Surgery Remimazolam Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

19 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Goyang, Gyeonggido, 10326, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Propofol

Drug

Propofol infusion with remifentanil

Remimazolam

Drug

Remimazolam infusion with remifentanil

Primary outcomes

  1. Respiratory insufficiency before surgery

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

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

  2. Respiratory insufficiency during surgery

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

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

Secondary outcomes

  1. Pain on injection

    Time frame: Just after the beginning of drug infusion

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

  2. Hypertension

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

    > 140 mmHg during Monitored Anesthetic Care (MAC)

  3. Hypotension

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

    < 90 mmHg during the Monitored Anesthetic Care

  4. Bradycardia

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

    Heart rate < 50/min during the Monitored Anesthetic Care

  5. Tachycardia

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

    Heart rate > 100/min during the Monitored Anesthetic Care

  6. Maximum ETCO2

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

    ETCO2 will be measured every single respiration in the nasal cavity

  7. Patient satisfaction with Monitored Anesthetic Care

    Time frame: Just before leaving the recovery room

    4-point rating scale on the Satisfaction with MAC

    (4: Fully satisfied, 3: Partially satisfied, 2: Partially unsatisfied,

    1: Totally unsatisfied)

  8. Postoperative Nausea/Vomiting (PONV)

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

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

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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