Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

NCT07076628 | Completed Phase 4

• 1 other identifier: J In 2021-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Respiratory insufficiency before surgery

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

  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%

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

Secondary Outcomes (8)

• Pain on injection

  Just after the beginning of drug infusion

• Hypertension

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

• Hypotension

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

• Bradycardia

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

• Tachycardia

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

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

Propofol infusion with remifentanil for hysteroscopic surgery

Drug: Propofol

Remimazolam group

ACTIVE COMPARATOR

Remimazolam infusion with remifentanil for hysteroscopic surgery

Drug: Remimazolam

Interventions

Propofol DRUG

Propofol infusion with remifentanil

Propofol group

Remimazolam DRUG

Remimazolam infusion with remifentanil

Remimazolam group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Gender Eligibility Details: with gynecologic surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

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

Goyang, Gyeonggido, 10326, South Korea

Location

Related Publications (5)

• 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.

  PMID: 34144683 BACKGROUND

• 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.

  PMID: 22190555 BACKGROUND

• 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.

  PMID: 22253270 BACKGROUND

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

  PMID: 32530890 BACKGROUND

• 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.

  PMID: 32417976 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Propofol; remimazolam

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Care giver will notice which drug will be given to the patients because of the color (White vs clear) and infusion doses of the drugs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be enrolled to one of the two drug groups with randomization.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: July 22, 2025
• Study Start: August 24, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

KR (1)