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Completed

NCT Number: NCT03741361

The Impact of Anxiety or Depression on the Sedative Concentration of Propofol

120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists (ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this cohort study. The day before surgery, participants will be assessed the state of preoperative anxiety and depression. On the day of surgery, propofol will be administered by target controlled infusion (TCI) pump. During induction of anesthesia, the level of sedation will be evaluated. The induction dose of propofol, target effect-site concentration(Cet), plasma concentration(Cp) and effect-site concentration (Ce) of propofol will be recorded.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists ( ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study. The day before surgery, participants were asked to complete the modified HADS questionnaire in an isolated calm room, and the score was used to assess the patients' anxiety and depression level in the past 6 months. On the day of surgery, propofol (Fresenius Kabi Austria GmbH, Graz, Austria)was administrated by using an intravenous target controlled infusion (TCI) pump (Alaris PK, Basingstoke, UK) with Schnider kinetic model. The initial effect-site concentration (Ce) was set as 1.0 μg/ml. After the TCI system displayed that Cp and Ce were at equilibrium, the target concentration of propofol was increased by an increment of 0.5 μg/ml until the patients achieved the three desired levels of sedation.The Ce and dose of propofol and the consuming time were recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female
  • American Society of Anesthesiologists(ASA) physical status I or II
  • Body Mass Index(BMI) 18-25kg/m2
  • scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia.

Exclusion criteria

  • suffering from psychiatric diseases.
  • chronic use of anxiolytics, antidepressants, and sedative-hypnotics.
  • any sedative premedication.
  • a history of alcohol abuse.
  • allergy to propofol.
  • declining to participate and cooperate.

Treatment and study plan

anxiety and depression

Other

Female patients who have a previous history of surgery or infertility, or a history of miscarriage or abortion are often susceptible to preoperative anxiety or depression. We will observe the effect of anxiety and depression on the dosage of propofol during induction.

Primary outcomes

  1. Effect-site concentration (Ce) of propofol

    Time frame: Time of induction is less than 10 minutes.

    Effect-site concentration (Ce) of propofol on the TCI-system at the sedative level of OAA/S score of 3, OAA/S score of 1, and OAA/S core of 1 and NI<64 reached will be recorded.

Secondary outcomes

  1. The induction dose of propofol

    Time frame: Time of induction is less than 10 minutes.

    The dose of propofol required at the sedative level of OAA/S score of 3, OAA/S score of 1, and OAA/S core of 1 and NI<64 reached will be recorded.

Sponsors and collaborators

Lead sponsor

Xuyu Zhang

Other

Registry information

Official study title

The Impact of Anxiety or Depression on the Sedative Concentration of Propofol in Day-case Hysteroscopic Surgery: a Prospective Observational Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Jul 9, 2019

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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