HypoxiaEROPNCT06004843
The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
A study testing remimazolam and Propofol in people with Hypoxia and Hysteroscopy, run by RenJi Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Hypoxia, Hysteroscopy, Overweight or Obesity
- What is being tested?
- remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Apr 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 50 years.
- Patients undergoing sedated hysteroscopy for assisted reproduction.
- ASA classification I-II.
- BMI ≥ 23 kg/㎡.
- Patients who have signed an informed consent form.
Who cannot join
- 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.
- Patients with severe renal insufficiency (requiring dialysis before surgery).
- Severe heart failure (METS < 4).
Show all 10Show fewer
- History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
- Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
- Breastfeeding women.
- Patients whom investigator believe are unsuitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital
Shanghai, Pudong New Area
yanhua he, B.S, +862168383702, 2339570124@qq.com
About this study
Official title: The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical 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 hypoxia during surgery between the two groups of patients.
- Conditions
- Hypoxia, Hysteroscopy, Overweight or Obesity
- Being tested
- remimazolam, Propofol
- Keywords
- hypoxia, hysteroscopy, Overweight or Obesity, remimazolam, propofol
- Medical subject headings
- Hypoxia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolamDrug
in this group,patients are treated with remimazolam and remifentanil for reduced sedation.
PropofolDrug
in this group,patients are treated with propofol and remifentanil for reduced sedation.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | In this group, participants are sedated with remimazolam and remifentanil. Receives: Drug: remimazolam |
| propofol | Active comparator | In this group, participants are sedated with propofol and remifentanil. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
75%≤ SpO2% ≤89% for<60s
Measured: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Secondary outcomes (3)
The incidence of sub-clinical respiratory depression
90%≤ SpO2<95%
Measured: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of severe hypoxia
SpO2<75% or 75%≤ SpO2≤89% for≥60s
Measured: 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
Measured: Participants will be followed for the duration of their hospital stay, with an expected average of 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 posted22 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004843
- Sponsor's protocol ID
- LY2023-115-A
- Acronym
- EROP
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Remimazolam on the Incidence of Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients: a Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06004843
- Acronym / sponsor ID
- EROP / LY2023-115-A
- Conditions
- Hypoxia, Hysteroscopy, Overweight or Obesity
- Keywords
- hypoxia, hysteroscopy, Overweight or Obesity, remimazolam, propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Aug 2023 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: remimazolamIn this group, participants are sedated with remimazolam and remifentanil. |
| propofol | Active comparator | Drug: PropofolIn this group, participants are sedated with propofol and remifentanil. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20 and 50 years.
- Patients undergoing sedated hysteroscopy for assisted reproduction.
- ASA classification I-II.
- BMI ≥ 23 kg/㎡.
- Patients who have signed an informed consent form.
Key exclusion criteria (10 listed)
- 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.
- Patients with severe renal insufficiency (requiring dialysis before surgery).
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 |
|---|---|---|
| remimazolamin this group,patients are treated with remimazolam and remifentanil for reduced sedation. | Drug | Remimazolam |
| Propofolin this group,patients are treated with propofol and remifentanil for reduced sedation. | Drug | propofol |
Primary outcome
The incidence of hypoxia
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
75%≤ SpO2% ≤89% for<60s
3 secondary outcomes
The incidence of sub-clinical respiratory depression
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
The incidence of severe hypoxia
Time frame: 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
Time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam and Propofol in people with Hypoxia and Hysteroscopy, run by RenJi Hospital at 1 site 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact diansan su, Dr (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia (time frame: Participants will be followed for the duration of their hospital stay, with an expected average of about 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2023.