Effect of Oxycodone on Anxiety State in Painless Abortion

NCT06435949 | Not Yet Recruiting Early Phase 1

• 1 other identifier: RJH-Anesth-HZH001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abortion Complication

Outcome Measures

Primary Outcomes (1)

• anxiety scores

  postoperative anxiety scores

  20-30 minutes postoperative

Secondary Outcomes (1)

• depression scores

  20-30 minutes postoperative

Study Arms (2)

group Fentanyl

EXPERIMENTAL

intravenous anesthesia with propofol with fentanyl

Drug: Fentanyl (as Citrate)

group Oxycodone

EXPERIMENTAL

intravenous anesthesia with propofol with oxycodone

Drug: Fentanyl (as Citrate)

Interventions

Fentanyl (as Citrate) DRUG

intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)

Also known as: Oxycodone

group Fentanyl; group Oxycodone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Interventions

Fentanyl; Oxycodone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share