Effect of Oxycodone on Anxiety State in Painless Abortion
Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Main observation indicators:
The difference between the post-operative anxiety score and the preoperative anxiety score
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
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group Fentanyl
intravenous anesthesia with propofol with fentanyl
|
intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)
Other Names:
|
|
Experimental: group Oxycodone
intravenous anesthesia with propofol with oxycodone
|
intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety scores
Time Frame: 20-30 minutes postoperative
|
postoperative anxiety scores
|
20-30 minutes postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depression scores
Time Frame: 20-30 minutes postoperative
|
postoperative depression scores
|
20-30 minutes postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJH-Anesth-HZH001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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