NCT06435949

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Abortion Complication

Interventions

Type	Name	Description
DRUG	Fentanyl (as Citrate)	intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-05-30
• Last updated: 2024-05-30