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

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ClinicalTrials.gov Identifier: NCT03741361
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment
Anxiety Depression Propofol Anesthetics, Intravenous Other: anxiety and depression

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Anxiety or Depression on the Sedative Concentration of Propofol in Day-case Hysteroscopic Surgery: a Prospective Observational Study
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Propofol

Group/Cohort Intervention/treatment
Anxiety and Depression
Female patients scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
An intravenous cannula was placed and 5 ml blood sample was drawn from each patient. The serum was separated and immediately stored at -80℃ for later analysis.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741361


Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Xuyu Zhang
Investigators
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Principal Investigator: Xuyu Zhang, M.D. and Ph.D Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University

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Responsible Party: Xuyu Zhang, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03741361     History of Changes
Other Study ID Numbers: SYSU 2018-11-02
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University:
Female
Prospective Studies
Anesthetics, Intravenous
Propofol
Anxiety/*psychology
Depression/*psychology

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics