Effect of Oxycodone on Anxiety State in Painless Abortion

Early Phase 1

Not yet recruiting

• Conditions: Abortion Complication
• Interventions: Drug: Fentanyl (as Citrate)

• Registration Number: NCT06435949
• Lead Sponsor: Ruijin Hospital

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

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Start: 2024-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Fentanyl	Fentanyl (as Citrate)	intravenous anesthesia with propofol with fentanyl
group Oxycodone	Fentanyl (as Citrate)	intravenous anesthesia with propofol with oxycodone

Primary Outcome Measures

Name	Time	Method
anxiety scores	20-30 minutes postoperative	postoperative anxiety scores

Secondary Outcome Measures

Name	Time	Method
depression scores	20-30 minutes postoperative	postoperative depression scores