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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03741361
Enrollment
120
Registered
2018-11-14
Start date
2018-11-27
Completion date
2019-02-15
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Intravenous, Anxiety, Depression, Propofol

Keywords

Female, Prospective Studies, Anesthetics, Intravenous, Propofol, Anxiety/*psychology, Depression/*psychology

Brief summary

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.

Detailed description

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.

Interventions

OTHERanxiety and depression

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.

Sponsors

Xuyu Zhang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect-site concentration (Ce) of propofolTime 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

MeasureTime frameDescription
The induction dose of propofolTime 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026