On respiratory depression and hypotension during induction of sedation Remimazolam vs. Propofol in Respiratory Suppression and Blood Pressure Reduction During Induction of Sedation.

On respiratory depression and hypotension during induction of sedation Remimazolam vs. Propofol in Respiratory Suppression and Blood Pressure Reduction During Induction of Sedation. Randomized, open-label, two-arm study - On respiratory depression and hypotension during induction of sedation Remimazolam vs. Propofol in Respiratory Suppression and Blood Pressure Reduction During Induction of Sedation. Randomized, open-label, two-arm study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071240114

Enrollment

Registered

2025-02-17

Start date

2025-02-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Interventions

Nagasaki University Hospital, Department of Anesthesia and Biomedical Management for patients undergoing dental treatment under intravenous sedation to measure and compare the effects on respiratory d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) Treatment: Adult patients who have been judged to require dental treatment (generally within 2 hours) under sedation and have visited the Department of Anesthesiology and Dental Anesthesiology at a university hospital (patients with dental treatment phobia, abnormal strangulation reflex, panic disorder, cerebral palsy, or other patients whose attending physician has judged that treatment under sedation is necessary). ii) Age: Adult patients who are at least 18 years old and less than 85 years old at the time of obtaining consent. (iii) Gender: Any gender (iv) Inpatient/Outpatient: Outpatient only (v) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.

Exclusion criteria

Exclusion criteria: (i) Patients with acute angle closure glaucoma (ii) Patients with myasthenia gravis (iii) Patients with a history of hypersensitivity to remimazolam and propofol (iv) Patients who are judged by the investigator to be inappropriate as research subjects.

Design outcomes

Primary

Measure	Time frame
1) Incidence of hypoxemia (SpO2 less than 90%) Definition of hypoxemia: SpO2 below 90% at least once during a procedure. Rationale: Because the evaluation of the incidence of hypoxemia (SpO2 less than 90%) is the best indicator of acid maintenance during dental procedures under sedation. 2) Incidence of hypotension (mean blood pressure of 65 mmHg or a 20% decrease from the baseline mean blood pressure (pre-sedation value))	—

Measure

Time frame

1) Incidence of hypoxemia (SpO2 less than 90%) Definition of hypoxemia: SpO2 below 90% at least once during a procedure. Rationale: Because the evaluation of the incidence of hypoxemia (SpO2 less than 90%) is the best indicator of acid maintenance during dental procedures under sedation. 2) Incidence of hypotension (mean blood pressure of 65 mmHg or a 20% decrease from the baseline mean blood pressure (pre-sedation value))

—

Secondary

Measure	Time frame
Elevated respiratory rate at optimal sedation level (>20% increase compared to baseline values before sedation)	—

Contacts

Public ContactShinji Kurata

Nagasaki University Hospital

kura@nagasaki-u.ac.jp+81-958197714

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026