Abortion Complication
Conditions
Brief summary
In this study, 300 patients who underwent painless abortion in Ruijin Hospital and sub-central hospitals were selected through a multi-center randomized controlled study, and 300 patients who underwent painless abortion in Ruijin Hospital and each sub-center hospital were divided into intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O) by stratified group randomization method 1:1. The difference between the postoperative anxiety scores and depression scores of the two groups was observed, and the postoperative anxiety, depression and numerical pain scores were recorded. Finally, the relevant data were statistically analyzed and conclusions were drawn.
Detailed description
This study is a multicenter, randomized controlled clinical study. A total of 300 patients who underwent elective painless abortion surgery in Ruijin Hospital and other sub-central hospitals were enrolled, and they were randomly divided into 1:1 patients who received intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O). The scores of anxiety, depression and postoperative numerical rating scale (NRS) before and after surgery were observed, and the levels of serum stress response factors and inflammatory cytokines were monitored. The effects of oxycodone on anxiety, depression and postoperative acute pain in patients with painless abortion were investigated. 1. Main observation indicators: The difference between the post-operative anxiety score and the preoperative anxiety score 2. Secondary Observational Indicators: * Post-operative anxiety score * The difference between the post-operative depression score and the preoperative depression score * Post-operative depression score * Pain assessment after surgical recovery (NRS) * Laboratory tests * Patient and family satisfaction with postoperative analgesic treatment
Interventions
intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-45 years old * Gestational age 6-12 weeks * American Society of Anesthesiologists （ASA） Grading I-II * Fluent communicator and able to complete self-rating scales on her own * Voluntarily participate and sign the informed consent form
Exclusion criteria
* Patients who are allergic to anesthetic drugs such as propofol, oxycodone, fentanyl, etc., or who have had other anesthetic adverse events * Patients with anxiety or depression * Presence of organic mental disorders, mental retardation * Severe acute and chronic infection, severe heart, liver and kidney insufficiency * Patients with complications or bleeding \> 50ml during surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety scores | 20-30 minutes postoperative | postoperative anxiety scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| depression scores | 20-30 minutes postoperative | postoperative depression scores |
Outcome results
None listed