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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 20 and 50 years.

Patients undergoing sedated hysteroscopy for assisted reproduction.

ASA classification I-II.

BMI ≥ 23 kg/㎡.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: RemimazolamExperimental treatment 1 intervention
Group B: propofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of severe hypoxia

SpO2\<75% or 75%≤ SpO2\<90% for≥60s

Time frame
people will be followed for the duration of hospital stay,an expected average about 2 hours

Secondary outcomes

1

The incidence of hypoxia

75%≤ SpO2% \<90% for\<60s

Time frame
people will be followed for the duration of hospital stay,an expected average about 2 hours
2

The incidence of sub-clinical respiratory depression

90%≤ SpO2\<95%

Time frame
people will be followed for the duration of hospital stay,an expected average about 2 hours
3

The incidence of other adverse events

Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Time frame
people will be followed for the duration of hospital stay,an expected average about 2 hours

Other outcomes

Sponsors and contacts

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