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Hypoxia is the most common adverse reaction during sedation outside the operating room.Exploring novel drug combinations to reduce the incidence of hypoxia during sedation in patients undergoing transvaginal oocyte retrieval procedures enhances patient safety and lowers perioperative adverse event rates. This multicenter, prospective, randomized, controlled clinical study will compare the hypoxia incidence rate of the remimazolam-alfentanil combination against the commonly used propofol-alfentanil combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol-alfentanil | Active Comparator | Sedation using remimazolam-alfentanil |
|
| remimazolam-alfentanil | Experimental | Sedation using remimazolam-alfentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam-alfentanil combination | Drug | Administer 7 μg/kg of fentanyl first,then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypoxia | SpO₂ between 75% and 89% with duration <60 seconds | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe hypoxia | SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Incidence of subclinical respiratory depression |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Dr. | Contact | +86-18616514088 | diansansu@yahoo.com | |
| Shuhan Gu, MD. | Contact | +86-13515813047 | shuhangu@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Not yet recruiting | Dongyang | Zhejiang | 322100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36471692 | Background | Zhang F, Chang H, Qing W, Yu R, Liao Q, Tong J. Remimazolam Tosylate Combined with Low-Dose Propofol Improves Sedation and Safety in Hysteroscopy. Drug Des Devel Ther. 2022 Nov 29;16:4101-4108. doi: 10.2147/DDDT.S390403. eCollection 2022. |
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| propofol-alfentanil | Drug | Administer 7 μg/kg of fentanyl first,then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion. |
|
90% ≤ SpO₂ < 95%
| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Proportion of hypoxic correction measures | Corrective measures for hypoxia should be implemented in the following sequence: increase oxygen flow rate, perform jaw thrust, administer positive pressure ventilation via a face mask, insert a nasopharyngeal airway while performing jaw thrust, and proceed to endotracheal intubation or mechanical ventilation with a laryngeal mask until SpO₂ reaches ≥95%. | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Lishui People's Hospital | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
|
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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