AnesthesiaPhase 4NCT05259787
EP Intravenous Anesthesia in Hysteroscopy
A Phase 4 study testing Sedation Etomidate combined with propofol and Sedation Propofol in people with Anesthesia, run by RenJi Hospital at 1 site in China.
Trial summary
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sedation Etomidate combined with propofol and Sedation Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to 30 Dec 2023
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective hysteroscopic surgery;
- intravenous anesthesia;
- normal reading and understanding ability
- volunteer to participate
Who cannot join
- serious complications such as heart failure, liver failure, pulmonary dysfunction, renal failure, etc.
- predictable difficult airway
- high risk of reflux aspiration
- allergy to propofol or etomidate
- already participated in other clinical trials within three months before admission
- unwilling to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Efficacy and Safety of Etomidate Combined with Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.
Read the detailed description
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. For hysteroscopic surgery using bipolar resectoscopes, hysteroscopic morcellators or shavers, it is considered efficient and safe to be performed under general anaesthesia, such as intravenous anesthesia. Propofol is one of the most commonly used intravenous anesthetics in clinic, however high dose propofol bring some potential clinical safety hazards, reducing respiratory rate and tidal volume, causing apnea or hypoxemia, and leading to hypoxia especially for obese and elderly patients. Propofol combined with etomidate as an improved scheme of intravenous anesthesia has been proved to have advantages in gastroendoscopy.In this study, the patients undergoing elective hysteroscopic surgery will be randomly assigned to two groups of intravenous anesthesia: Etomidate combined with propofol of 1:2 ratio (EP) versus Propofol (P). The sedation degree, respiratory related events (hypoxia, asphyxia incidence and maintenance time) and hemodynamic events，integrated pulmonary index (IPI) of the two groups will be evaluated to explore the feasibility and safety of the clinical application of EP mixture in hysteroscopic surgery.
- Conditions
- Anesthesia
- Being tested
- Sedation Etomidate combined with propofol, Sedation Propofol
- Keywords
- propofol, etomidate, intravenous anesthesia, hysteroscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation Etomidate combined with propofolDrug
Also called EP
Drug IV within 10 second during anesthesia induction.
Sedation PropofolDrug
Also called EP
Drug IV within 10 second during anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate combined with propofol（EP） | Experimental | 0.2ml/kg IV Receives: Drug: Sedation Etomidate combined with propofol |
| Propofol（P） | Active comparator | 0.2ml/kg IV Receives: Drug: Sedation Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified observer's assessment of alert /sedation scores (MOAAS scores)
Modified observer's assessment of alert /sedation score 0-2 as effective anesthesia for hysteroscopic procedures.The MOAAS scores is a 6-point scale that assesses the responsiveness of patients and coincides with the ASA continuum of sedation. A patient with a score of 5 responds readily to name spoken in a normal tone, 4 lethargic response to name spoken in a normal tone, 3 responds only after the name is called loudly and/or repeatedly, 2 responds only after mild prodding or shaking, 1 responds only after painful trapezius squeeze, and 0 does not respond to painful trapezius squeeze (0 to 1 deep sedation, 2 to 4 moderate sedation, and 5 minimal sedation or alert).
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Apnea duration
The time duration from the disappearance to the recovery of spontaneous breathing, record in seconds.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (4)
Incidence of manual ventilation intervention
When Pulse Oxygen Saturation(SpO2)<90% ，mask pressure ventilation or mechanical ventilation should be used as the intervention. The intervention incidence will be record in percentage.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Pulse oxygen saturation (SpO2)
Pulse oxygen saturation (SpO2) will be recorded in percentage, range from 0 to 100%.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Blood Pressure(BP)
Noninvasive blood pressure will be recorded in mmHg.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Heart rate (HR)
Heart rate (HR) will be recorded in times/min.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start28 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diansan Su, MD,PHD, Study director, Renji Hospital, Shanghai Jiaotong University, School of Medcine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259787
- Sponsor's protocol ID
- EP hysteroscopy
- Status last verified
- Nov 2022
- First submitted
- 20 Dec 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Etomidate Combined with Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05259787
- Acronym / sponsor ID
- EP hysteroscopy
- Conditions
- Anesthesia
- Keywords
- propofol, etomidate, intravenous anesthesia, hysteroscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 2 Mar 2022 (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.
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.
Detailed description
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. For hysteroscopic surgery using bipolar resectoscopes, hysteroscopic morcellators or shavers, it is considered efficient and safe to be performed under general anaesthesia, such as intravenous anesthesia. Propofol is one of the most commonly used intravenous anesthetics in clinic, however high dose propofol bring some potential clinical safety hazards, reducing respiratory rate and tidal volume, causing apnea or hypoxemia, and leading to hypoxia especially for obese and elderly patients. Propofol combined with etomidate as an improved scheme of intravenous anesthesia has been proved to have advantages in gastroendoscopy.In this study, the patients undergoing elective hysteroscopic surgery will be randomly assigned to two groups of intravenous anesthesia: Etomidate combined with propofol of 1:2 ratio (EP) versus Propofol (P). The sedation degree, respiratory related events (hypoxia, asphyxia incidence and maintenance time) and hemodynamic events，integrated pulmonary index (IPI) of the two groups will be evaluated to explore the feasibility and safety of the clinical application of EP mixture in hysteroscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate combined with propofol（EP） | Experimental | Drug: Sedation Etomidate combined with propofol0.2ml/kg IV |
| Propofol（P） | Active comparator | Drug: Sedation Propofol0.2ml/kg IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective hysteroscopic surgery;
- intravenous anesthesia;
- normal reading and understanding ability
- volunteer to participate
Key exclusion criteria (6 listed)
- serious complications such as heart failure, liver failure, pulmonary dysfunction, renal failure, etc.
- predictable difficult airway
- high risk of reflux aspiration
- allergy to propofol or etomidate
- already participated in other clinical trials within three months before admission
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 |
|---|---|---|
| Sedation Etomidate combined with propofolAlso: EPDrug IV within 10 second during anesthesia induction. | Drug | Etomidate combined with propofol（EP） |
| Sedation PropofolAlso: EPDrug IV within 10 second during anesthesia induction. | Drug | Propofol（P） |
Primary outcome
Modified observer's assessment of alert /sedation scores (MOAAS scores)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Modified observer's assessment of alert /sedation score 0-2 as effective anesthesia for hysteroscopic procedures.The MOAAS scores is a 6-point scale that assesses the responsiveness of patients and coincides with the ASA continuum of sedation. A patient with a score of 5 responds readily to name spoken in a normal tone, 4 lethargic response to name spoken in a normal tone, 3 responds only after the name is called loudly and/or repeatedly, 2 responds only after mild prodding or shaking, 1 responds only after painful trapezius squeeze, and 0 does not respond to painful trapezius squeeze (0 to 1 deep sedation, 2 to 4 moderate sedation, and 5 minimal sedation or alert).
Apnea duration
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time duration from the disappearance to the recovery of spontaneous breathing, record in seconds.
4 secondary outcomes
Incidence of manual ventilation intervention
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Pulse oxygen saturation (SpO2)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Blood Pressure(BP)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Heart rate (HR)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 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 28 Feb 2025.
- 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.
Diansan Su, MD,PHD study director
Renji Hospital, Shanghai Jiaotong University, School of Medcine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sedation Etomidate combined with propofol and Sedation Propofol in people with Anesthesia, 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 4 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 28 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Modified observer's assessment of alert /sedation scores (MOAAS scores) (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). The study lists 2 primary outcomes in all. 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 Feb 2025.