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

NCT03741361 | Completed DMC

• 1 other identifier: SYSU 2018-11-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Propofol; Anesthetics, Intravenous

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effect-site concentration (Ce) of propofol

  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.

  Time of induction is less than 10 minutes.

Secondary Outcomes (1)

• The induction dose of propofol

  Time of induction is less than 10 minutes.

Study Arms (1)

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

Interventions

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.

Anxiety and Depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuyu Zhang: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 32445415 DERIVED

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.

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xuyu Zhang, M.D. and Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 14, 2018
• Study Start: November 27, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 15, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication.

Locations

CN (1)