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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | In this group, participants are sedated with remimazolam and remifentanil. |
|
| propofol | Active Comparator | In this group, participants are sedated with propofol and remifentanil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam | Drug | in this group,patients are treated with remimazolam and remifentanil for reduced sedation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxia | 75%≤ SpO2% ≤89% for<60s | Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sub-clinical respiratory depression | 90%≤ SpO2<95% | Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours. |
| The incidence of severe hypoxia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| diansan su, Dr | Contact | +862168383702 | diansansu@yahoo.com | |
| yanhua he, B.S | Contact | +862168383702 | 2339570124@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Pudong New Area | China |
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| Propofol | Drug | in this group,patients are treated with propofol and remifentanil for reduced sedation. |
|
SpO2<75% or 75%≤ SpO2≤89% for≥60s
| Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours. |
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours. |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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