Clinical trial NCT03741361: The Impact of Anxiety or Depression on the Sedative Concentration of Propofol
Official title: The Impact of Anxiety or Depression on the Sedative Concentration of Propofol in Day-case Hysteroscopic Surgery: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Propofol
Anesthetics, Intravenous
Keywords: Female
Prospective Studies
Anesthetics, Intravenous
Propofol
Anxiety/*psychology
Depression/*psychology
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients, 18-65 years old, American Society of Anesthesiologists （ASA） physical status I or II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia in the first affiliated hospital of Sun Yat-sen University in Guangzhou, China will be recruited in this cohort study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect-site concentration (Ce) of propofol
timeFrame: Time of induction is less than 10 minutes.
Secondary outcomes:
measure: The induction dose of propofol
timeFrame: Time of induction is less than 10 minutes.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
name: Xuyu Zhang, M.D. and Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li RY, Lin M, Jiang HY, Wen SH, Shen JT, Huang WQ, Zhang XY. Impact of Anxiety or Depression Symptoms on Propofol Requirements for Sedation in Females: A Prospective Cohort Study. J Clin Pharmacol. 2020 Oct;60(10):1376-1384. doi: 10.1002/jcph.1631. Epub 2020 May 23.