HypoxiaNCT07335536
The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval
A study testing remimazolam-alfentanil combination and propofol-alfentanil in people with Hypoxia and Infertility, run by Diansan Su at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypoxia, Infertility, Infertility Assisted Reproductive Technology
- What is being tested?
- remimazolam-alfentanil combination and propofol-alfentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
- Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Dongyang People's Hospital
Dongyang, Zhejiang, 322100
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieva
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.
- Being tested
- remimazolam-alfentanil combination, propofol-alfentanil
- Keywords
- Hypoxia, oocyte retrieval, remimazolam, general anesthesia
- Medical subject headings
- Hypoxia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam-alfentanil combinationDrug
Administer 7 μg/kg of alfentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion.
propofol-alfentanilDrug
Administer 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion.
| Study group | Role | What they receive |
|---|---|---|
| propofol-alfentanil | Active comparator | Sedation using remimazolam-alfentanil Receives: Drug: propofol-alfentanil |
| remimazolam-alfentanil | Experimental | Sedation using remimazolam-alfentanil Receives: Drug: remimazolam-alfentanil combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypoxia
SpO₂ between 75% and 89% with duration <60 seconds
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (3)
Incidence of severe hypoxia
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
90% ≤ SpO₂ < 95%
Measured: 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%.
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start20 Oct 2025
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diansan Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335536
- Sponsor's protocol ID
- ZJU2025C086
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36471692
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieva
- ClinicalTrials.gov ID
- NCT07335536
- Acronym / sponsor ID
- ZJU2025C086
- Keywords
- Hypoxia, oocyte retrieval, remimazolam, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Diansan SuUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol-alfentanil | Active comparator | Drug: propofol-alfentanilSedation using remimazolam-alfentanil |
| remimazolam-alfentanil | Experimental | Drug: remimazolam-alfentanil combinationSedation using remimazolam-alfentanil |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged 18 to 50 years planning to undergo painless oocyte retrieval
- Subjects classified as American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remimazolam-alfentanil combinationAdminister 7 μg/kg of alfentanyl first，then given remimazolam 0.2 mg/kg (1-minute bolus), followed by 1 mg/kg/h infusion. | Drug | remimazolam-alfentanil |
| propofol-alfentanilAdminister 7 μg/kg of fentanyl first，then given propofol 2 mg/kg (1-minute bolus), followed by 6 mg/kg/h infusion. | Drug | propofol-alfentanil |
Primary outcome
Incidence of Hypoxia
Time frame: 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
3 secondary outcomes
Incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of subclinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Proportion of hypoxic correction measures
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 36471692Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam-alfentanil combination and propofol-alfentanil in people with Hypoxia and Infertility, run by Diansan Su at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07335536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.