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

JRCT ID: jRCTs071240114

Registered date:17/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dental Caries
• Date of first enrollment: 17/02/2025
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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 depression and hypotension during induction at the stage of reaching optimal sedation level in the following two groups.
Study drug group: Sedation with remimazolam (off-label use)
Control drug group: Sedation with propofol (Nagasaki University Hospital, approved for off-label use)
Transcutaneous oxygen saturation and respiratory rate are measured continuously with Nellcore 1000 and noninvasively with a fingertip blood pressure monitor (Figure 1: NIBP system for humans, ADInstruments).
The definition of hypotension is defined as the onset of hypotension with a mean blood pressure of 65 mmHg or a 20% decrease from the basal (pre-sedation) value of the mean blood pressure.
Respiratory depression is defined as a transcutaneous oxygen saturation of 90% or less.
For intravenous sedation, a venous channel is secured in the patient's upper arm, elbow fossa, or dorsal hand, and the drug is administered through a three-way stopcock after connecting the infusion with extracellular fluid.
In the remimazolam group, a single dose of remimazolam 0.05 mg/kg is followed by continuous administration by syringe pump (0.40-0.60 mg/kg/hr). (Oue K. BMC Oral Health,2023) (Kim H.J. Can J Anesth,2023)
In the propofol group, propofol is administered continuously by syringe pump (TCI 1.5-2.0 microg/ml: 3-4 mg/kg/hr continuous).
The sedation level of both drugs should be kept constant (the depth of sedation at which dental procedures can be performed in each case), and the standard sedation level should be the transition from moderate sedation to deep sedation (moderate sedation to deep sedation) of the sedation guidelines (Ramsay score 3-5, and BIS score 60-70). Remimazolam and propofol should be continued under the judgment of the dental anesthesiologist until the dental procedure is completed.

Outcome(s)

Primary Outcome

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 Outcome: Elevated respiratory rate at optimal sedation level (>20% increase compared to baseline values before sedation)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kurata Shinji