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

NCT ID: NCT03741361

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-27

Study Completion Date

2019-02-15

Brief Summary

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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

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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.

Conditions

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Anxiety Depression Propofol Anesthetics, Intravenous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anxiety and Depression

Female patients scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study.

anxiety and depression

Intervention Type 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.

Interventions

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anxiety 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xuyu Zhang

OTHER

Sponsor Role lead

Responsible Party

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Xuyu Zhang

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xuyu Zhang, M.D. and Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32445415 (View on PubMed)

Other Identifiers

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SYSU 2018-11-02

Identifier Type: -

Identifier Source: org_study_id

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