EP Intravenous Anesthesia in Hysteroscopy

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Sedation Etomidate combined with propofol; Drug: Sedation Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05259787

EP hysteroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

---

366 participants in 2 patient groups

Etomidate combined with propofol（EP）

Experimental group

Description:

0.2ml/kg IV

Treatment:

Drug: Sedation Etomidate combined with propofol

Propofol（P）

Active Comparator group

Description:

0.2ml/kg IV

Treatment:

Drug: Sedation Propofol