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NCT Number: NCT05259787

EP Intravenous Anesthesia in Hysteroscopy

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.

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation Etomidate combined with propofol

Drug

Drug IV within 10 second during anesthesia induction.

Other names: EP

Sedation Propofol

Drug

Drug IV within 10 second during anesthesia induction.

Other names: EP

Primary outcomes

  1. Modified observer's assessment of alert /sedation scores (MOAAS scores)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    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).

  2. Apnea duration

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    The time duration from the disappearance to the recovery of spontaneous breathing, record in seconds.

Secondary outcomes

  1. Incidence of manual ventilation intervention

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    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.

  2. Pulse oxygen saturation (SpO2)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    Pulse oxygen saturation (SpO2) will be recorded in percentage, range from 0 to 100%.

  3. Blood Pressure(BP)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    Noninvasive blood pressure will be recorded in mmHg.

  4. Heart rate (HR)

    Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

    Heart rate (HR) will be recorded in times/min.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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