EP Intravenous Anesthesia in Hysteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Efficacy and Safety of Etomidate Combined With Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sedation Etomidate combined with propofol
* Drug: Sedation Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective hysteroscopic surgery; intravenous anesthesia; normal reading and understanding ability volunteer to participate Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etomidate combined with propofol（EP）<br>0.2ml/kg IV | Drug: Sedation Etomidate combined with propofol<br>* Drug IV within 10 second during anesthesia induction.<br>* Other names: EP;|
| Active Comparator: Propofol（P）<br>0.2ml/kg IV | Drug: Sedation Propofol<br>* Drug IV within 10 second during anesthesia induction.<br>* Other names: EP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, etomidate, intravenous anesthesia, hysteroscopic surgery