Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435949
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-31
Brief Title:
Effect of Oxycodone on Anxiety State in Painless Abortion
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None