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

Completed

• Conditions: Anxiety; Depression; Anesthetics, Intravenous; Propofol
• Interventions: Other: anxiety and depression

• Registration Number: NCT03741361
• Lead Sponsor: Xuyu Zhang

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.

Study Timeline

• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-14
• Study Start: 2018-11-27
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-07
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anxiety and Depression	anxiety and depression	Female patients scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study.

Primary Outcome Measures

Name	Time	Method
Effect-site concentration (Ce) of propofol	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

Name	Time	Method
The induction dose of propofol	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China