Clinical trial NCT05259787: EP Intravenous Anesthesia in Hysteroscopy
Official title: Efficacy and Safety of Etomidate Combined with Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: propofol
etomidate
intravenous anesthesia
hysteroscopic surgery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 366
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified observer's assessment of alert /sedation scores (MOAAS scores)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Apnea duration
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Incidence of manual ventilation intervention
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Pulse oxygen saturation (SpO2)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Blood Pressure(BP)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Heart rate (HR)
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, Shanghai Jiaotong University, School of Medcine
name: Diansan Su, MD,PHD
role: STUDY_DIRECTOR
References: