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Evaluation method for intravenous sedation using JINS MEME

Development of moderate sedation state and recovery process evaluation method for intravenous sedation using JINS MEME

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250051
Enrollment
20
Registered
2025-06-25
Start date
2025-06-25
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

Healthy Adults

Interventions

The study will be a randomized, crossover, comparative study of three groups of the same study subjects receiving saline (Group 1), or propofol (Group 2). The study will be conducted in a single blind

Sponsors

Kishimoto Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Healthy adult males between the ages of 20 and 39 (2) Those who have given their consent to participate in this research by signing the consent form.

Exclusion criteria

Exclusion criteria: (1) Persons at risk of airway obstruction (obesity, history of sleep apnea syndrome, etc.) (2) Patients with a history of hypersensitivity to any of the ingredients of Propofol (3) Patients taking psychotropic drugs (including those taking sleeping pills or other drugs taken on an ad-hoc basis) (4) Patients with serious hepatic disorder, renal disorder, respiratory disease, or cardiac disease (5) Patients with an implantable pacemaker or an implantable cardioverter-defibrillator (6) Persons who are judged to be ineligible by the principal investigator (dentist).

Design outcomes

Primary

MeasureTime frame
Eye potential (blink intensity, blink duration, blink frequency)

Secondary

MeasureTime frame
Body sway, BIS (electroencephalogram spectrum) values, Modified Observer's Assessment of Alertness/Sedation (MOAA/S), directed behavior, cognitive ability, Trieger Dot Test, center of gravity sway distance and area, cardiovascular parameters (blood pressure, pulse rate), respiratory parameters (arterial blood oxygen saturation (SpO2), expiratory terminal carbon dioxide partial pressure (etCO2), respiratory rate), incidence of adverse events and failures

Contacts

Public ContactToshiyuki Kishimoto

Asahi University Medical & Dental Center

kishimototoshiyuki@dent.asahi-u.ac.jp+81-58-329-1112

Outcome results

None listed

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