Evaluate sedation depth using Perfusion Index

JRCT ID: jRCT1041220077

Registered date:20/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult: Predict complications such as airway obstruction under sedation
• Date of first enrollment: 02/11/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

After measuring control values, administer a continuous dose (Target control infusion:1.5) of propofol.
Trial A:Observe for 15 minutes during propofol administration.
Trial B:Perform 15 minutes of oral cleaning during propofol administration.
Each trial will be conducted with subjects on different days.

Outcome(s)

• Primary Outcome: Changes in Perfusion Index (PI) due to differences in sedative dose / maintenance dose

Secondary Outcome

1. Bispectral Index(BIS value)
2. Modified observer assessment of alertness / sedation scale(MOAA/S)
3. SpO2, EtCO2, respiratory rate
4. blood pressure, pulse rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age 11month 4weeks old
• Gender: Male

Include criteria

1. Male
2. 20 to 39 old over
3. American Society of Anesthesiologist Physical Status Classification(ASA PS) 1-2
4. BMI less than 30
5. Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study

Exclude criteria

1. ASA PS 3 over
2. Patients with a history of hypersensitivity to propofol
3. Medicine users
4. Person who the research director judged inappropriate as a research subject

Related Information

• Primary Sponsor: Hayashi Shintaro