Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187896
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-17
Brief Title:
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients a Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RP
Brief Summary:
Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction and it is more likely to occur in overweight or obese patients In sedated gastroscopy the incidence of hypoxia with remimazolam is lower than that with propofol The present study is a single-center randomized single-blind controlled clinical trial Overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment with ASA grade I or II were selected as subjects and randomly divided into an experimental group and a control group with 300 subjects in each group Sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil respectively to compare the incidence of severe hypoxia during surgery between the two groups of patients
Detailed Description:
None
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