Back to resultsThe Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients (EROP)
Primary Purpose
Hypoxia, Hysteroscopy, Overweight or Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
remimazolam
Propofol
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring hypoxia, hysteroscopy, Overweight or Obesity, remimazolam, propofol
Eligibility Criteria
Inclusion Criteria: Age between 20 and 50 years. Patients undergoing sedated hysteroscopy for assisted reproduction. ASA classification I-II. BMI ≥ 23 kg/㎡. Patients who have signed an informed consent form. Exclusion Criteria: SpO2 < 95% in patients inhaling air upon entering the room. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy. Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc. Patients with severe liver dysfunction. Patients with severe renal insufficiency (requiring dialysis before surgery). Severe heart failure (METS < 4). History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol). Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products. Breastfeeding women. Patients whom investigator believe are unsuitable for participating in this trial.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remimazolam
propofol
Arm Description
In this group, participants are sedated with remimazolam and remifentanil.
In this group, participants are sedated with propofol and remifentanil.
Outcomes
Primary Outcome Measures
The incidence of hypoxia
75%≤ SpO2% ≤89% for<60s
Secondary Outcome Measures
The incidence of sub-clinical respiratory depression
90%≤ SpO2<95%
The incidence of severe hypoxia
SpO2<75% or 75%≤ SpO2≤89% for≥60s
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06004843
Brief Title
The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
Acronym
EROP
Official Title
The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 hypoxia during surgery between the two groups of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hysteroscopy, Overweight or Obesity
Keywords
hypoxia, hysteroscopy, Overweight or Obesity, remimazolam, propofol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
In this group, participants are sedated with remimazolam and remifentanil.
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
In this group, participants are sedated with propofol and remifentanil.
Intervention Type
Drug
Intervention Name(s)
remimazolam
Intervention Description
in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
in this group,patients are treated with propofol and remifentanil for reduced sedation.
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
75%≤ SpO2% ≤89% for<60s
Time Frame
Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Secondary Outcome Measure Information:
Title
The incidence of sub-clinical respiratory depression
Description
90%≤ SpO2<95%
Time Frame
Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Title
The incidence of severe hypoxia
Description
SpO2<75% or 75%≤ SpO2≤89% for≥60s
Time Frame
Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Title
The incidence of other adverse events
Description
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time Frame
Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 50 years.
Patients undergoing sedated hysteroscopy for assisted reproduction.
ASA classification I-II.
BMI ≥ 23 kg/㎡.
Patients who have signed an informed consent form.
Exclusion Criteria:
SpO2 < 95% in patients inhaling air upon entering the room.
Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.
Patients with severe liver dysfunction.
Patients with severe renal insufficiency (requiring dialysis before surgery).
Severe heart failure (METS < 4).
History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
Breastfeeding women.
Patients whom investigator believe are unsuitable for participating in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
diansan su, Dr
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
yanhua he, B.S
Phone
+862168383702
Email
2339570124@qq.com
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Pudong New Area
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yanhua he, B.S
Phone
+862168383702
Email
2339570124@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
We'll reach out to this number within 24 hrs