Clinical trial

The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT06187896

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 50 Years

SexFemale

Healthy volunteersNot accepted

ConditionHypoxia, Hysteroscopy, Overweight or Obesity

Full registry criteria

Inclusion Criteria: 1. Age between 20 and 50 years. 2. Patients undergoing sedated hysteroscopy for assisted reproduction. 3. ASA classification I-II. 4. BMI ≥ 23 kg/㎡. 5. Patients who have signed an informed consent form. Exclusion Criteria: 1. SpO2 \< 95% in patients inhaling air upon entering the room. 2. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy. 3. 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. 4. Patients with severe liver dysfunction. 5. Patients with severe renal insufficiency (requiring dialysis before surgery). 6. Severe heart failure (METS \< 4). 7. 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). 8. Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products. 9. Breastfeeding women. 10. Patients whom investigator believe are unsuitable for participating in this trial.

Treatments and study arms

remimazolam

Drug

in this group,patients are treated with remimazolam and remifentanil for reduced sedation.

Propofol

Drug

in this group,patients are treated with propofol and remifentanil for reduced sedation.

Primary outcomes

The incidence of severe hypoxiapeople will be followed for the duration of hospital stay,an expected average about 2 hours

SpO2\<75% or 75%≤ SpO2\<90% for≥60s

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Diansan Su🇨🇳 Shanghai, Shanghai Municipality, China

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