EP Intravenous Anesthesia in Hysteroscopy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259787
• Other study ID #: EP hysteroscopy
• Status: Recruiting
• Phase: Phase 4
• Start date: September 28, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: RenJi Hospital
• Contact: Jie Xiao, MD,PHD
• Phone: +86 13817931390
• Email: applexiaomz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sedation Etomidate combined with propofol
Drug IV within 10 second during anesthesia induction.
• Sedation Propofol
Drug IV within 10 second during anesthesia induction.

Locations

Country	Name	City	State
China	Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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