## Protocol Section
### Identification Module
**NCT ID:** NCT06435949

**Brief Title:** Effect of Oxycodone on Anxiety State in Painless Abortion

**Official Title:** Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial

#### Organization Study ID Info
**ID:** RJH-Anesth-HZH001
#### Organization
**Class:** OTHER
**Full Name:** Ruijin Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-31
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ruijin Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Abortion Complication

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** intravenous anesthesia with propofol with fentanyl

**Intervention Names:**

- Drug: Fentanyl (as Citrate)

**Label:** group Fentanyl

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** intravenous anesthesia with propofol with oxycodone

**Intervention Names:**

- Drug: Fentanyl (as Citrate)

**Label:** group Oxycodone

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group Fentanyl

- group Oxycodone

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

**Name:** Fentanyl (as Citrate)

**Other Names:**

- Oxycodone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** postoperative anxiety scores

**Measure:** anxiety scores

**Time Frame:** 20-30 minutes postoperative

#### Secondary Outcomes

**Description:** postoperative depression scores

**Measure:** depression scores

**Time Frame:** 20-30 minutes postoperative

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: HIGH

- As Found: Traditional use

- ID: M13020

- Name: Oxycodone

- Relevance: HIGH

- As Found: Valve

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M21320

- Name: Citric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M1837

- Name: Sodium Citrate

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: HIGH

- As Found: Free

### Intervention Browse Module - Meshes

- ID: D000005283

- Term: Fentanyl

- ID: D000010098

- Term: Oxycodone

### Misc Info Module

- Version Holder: 2024-05-31
