Abortion ComplicationEarly Phase 1NCT06435949
Effect of Oxycodone on Anxiety State in Painless Abortion
A Early Phase 1 study testing Fentanyl (as Citrate) in people with Abortion Complication, run by Ruijin Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Complication
- What is being tested?
- Fentanyl (as Citrate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Main observation indicators: The difference between the post-operative anxiety score and the preoperative anxiety score
- 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
- Being tested
- Fentanyl (as Citrate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (as Citrate)Drug
Also called Oxycodone
intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)
| Study group | Role | What they receive |
|---|---|---|
| group Fentanyl | Experimental | intravenous anesthesia with propofol with fentanyl Receives: Drug: Fentanyl (as Citrate) |
| group Oxycodone | Experimental | intravenous anesthesia with propofol with oxycodone Receives: Drug: Fentanyl (as Citrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety scores
postoperative anxiety scores
Measured: 20-30 minutes postoperative
Secondary outcomes (1)
depression scores
postoperative depression scores
Measured: 20-30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion ComplicationStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435949
- Sponsor's protocol ID
- RJH-Anesth-HZH001
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06435949
- Acronym / sponsor ID
- RJH-Anesth-HZH001
- Conditions
- Abortion Complication
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Main observation indicators: The difference between the post-operative anxiety score and the preoperative anxiety score
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group Fentanyl | Experimental | Drug: Fentanyl (as Citrate)intravenous anesthesia with propofol with fentanyl |
| group Oxycodone | Experimental | Drug: Fentanyl (as Citrate)intravenous anesthesia with propofol with oxycodone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl (as Citrate)Also: Oxycodoneintravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone) | Drug | group Fentanyl, group Oxycodone |
Primary outcome
anxiety scores
Time frame: 20-30 minutes postoperative
postoperative anxiety scores
1 secondary outcome
depression scores
Time frame: 20-30 minutes postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fentanyl (as Citrate) in people with Abortion Complication, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety scores (time frame: 20-30 minutes postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.