Hypoxia, Infertility, Infertility Assisted Reproductive Technology
Conditions
Keywords
Hypoxia, oocyte retrieval, remimazolam, general anesthesia
Brief summary
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.
Interventions
Administer 7 μg/kg of fentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.
DRUGpropofol-alfentanil
Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.
Sponsors
Diansan Su
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval * Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
Exclusion criteria
* Subjects with contraindications to general anesthesia, acute or severe cardiovascular disease history, acute upper respiratory infection, chronic obstructive pulmonary disease (COPD), asthma attacks, or uncontrolled hypertension * Subjects with alcohol abuse * Subjects with severe hepatic or renal insufficiency, severe cardiovascular disease, or psychiatric disorder history * Subjects with hearing impairment preventing communication * Subjects with a history of long-term sedative or opioid use, or allergies to benzodiazepines, flumazenil, opioids and their antidotes, propofol, eggs, or soy products * Subjects with SpO2 \< 95% while breathing room air after entering the room
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO₂ between 75% and 89% with duration \<60 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s |
| Incidence of subclinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 90% ≤ SpO₂ \< 95% |
| Proportion of hypoxic correction measures | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 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%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence of other adverse events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
Countries
China
Contacts
Primary ContactDiansan Su, Dr.
Backup ContactShuhan Gu, MD.
Outcome results
None listed