Effects of Postpartum Depression on Anesthetics

JRCT ID: jRCT1011220002

Registered date:22/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: intrauterine fetal death and mid-term abortion
• Date of first enrollment: 22/04/2022
• Target sample size: 80
• Study type: Interventional
• Intervention(s): After obtaining consent from the patient, the patient will be randomly assigned to receive propofol or dexmedetomidine. Intervention begins when a labor attack appears. Start administration of both propofol and dexmedetomidine according to the protocol, and adjust the drug to a sedation level of Ramsay Sedation Sore 2. For analgesia, fentanyl is used in all groups, and the Numeric Rating Scale is adjusted to 0 to 3. Depression is assessed using BDI-II, a self-assessment scale that assesses depression before and 2-4 weeks after delivery. The primary endpoint is the evaluation of depressive state by BDI-II, and the secondary endpoints are drug use, sedation / analgesia scoring, delivery time, patient respiratory and circulatory dynamics, bleeding volume, and the presence or absence of complications.

Outcome(s)

• Primary Outcome: Evaluation of depression by BDI-II
• Secondary Outcome: Narcotic use, sedation / analgesia scoring, delivery time, patient respiratory and circulatory dynamics, bleeding volume, presence or absence of complications

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: Patients who delivered due to intrauterine fetal death and mid-term abortion at our hospital
• Exclude criteria: a history of allergies to propofol, dexmedetomidine, or fentanyl, contraindication for propofol or dexmedetomidine, or do not consent to the patient.

Related Information

• Primary Sponsor: Kimizuka Motonobu