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New treatment option for Hypoxia
Official title The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
ClinicalTrials.gov ID: NCT06187896
What this study is testing
What is remimazolam?
remimazolam is an investigational medicine, being studied as a potential treatment for hypoxia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 50, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease...
- Patients with severe liver dysfunction.
- Patients with severe renal insufficiency (requiring dialysis before surgery).
- Severe heart failure (METS \< 4).
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.