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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etomidate combined with propofol（EP） | Experimental | 0.2ml/kg IV |
|
| Propofol（P） | Active Comparator | 0.2ml/kg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation Etomidate combined with propofol | Drug | Drug IV within 10 second during anesthesia induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, MD,PHD | Renji Hospital, Shanghai Jiaotong University, School of Medcine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Sedation Propofol | Drug | Drug IV within 10 second during anesthesia induction. |
|
|
| Pulse oxygen saturation (SpO2) |
Pulse oxygen saturation (SpO2) will be recorded in percentage, range from 0 to 100%. |
| 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. | 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. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |