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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abortion Complication
• Intervention / Treatment: Drug: Fentanyl (as Citrate)

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group Fentanyl; intravenous anesthesia with propofol with fentanyl	Drug: Fentanyl (as Citrate); intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone); Other Names: Oxycodone
Experimental: group Oxycodone; intravenous anesthesia with propofol with oxycodone	Drug: Fentanyl (as Citrate); intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone); Other Names: Oxycodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety scores	postoperative anxiety scores	20-30 minutes postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depression scores	postoperative depression scores	20-30 minutes postoperative

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Oxycodone
• Other Study ID Numbers: RJH-Anesth-HZH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No