Memory During Inhalation Anesthesia Performed With or Without Bispectral Index (BIS) in Patients Undergoing Thyroidectomy

• Conditions: Thyroidectomy
• Interventions: Drug: Inhaled anesthetics

• Registration Number: NCT01146431
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

The purpose of this study is 1) to investigate whether the use of BIS as a guide to the administration of inhaled anesthetic (sevoflurane or desflurane) compared with the use of hemodynamic parameters (blood pressure and heart rate) would affect the occurrence of implicit memory and /or dreams recall and 2) to check whether the occurrence of implicit memory and/or dreams recall is related with MAC (Minimal Alveolar Concentration) of inhalational anesthetics and/or preoperative anxiety levels.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Age between 18 and 70 years
• Class-ASA Physical Status I-II

Exclusion Criteria

• Psychiatric or neurological disorders and/or hearing disorders
• Obesity (Body Mass Index > 30)
• Drug addiction, alcoholism
• Patient with difficulty in understanding italian language and/or education level below middle school

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodynamic parameters	Inhaled anesthetics	Hemodynamic parameters will be used as a guide for anesthesia.
BIS	Inhaled anesthetics	Bispectral Index (BIS) will be used as a guide for anesthesia.

Primary Outcome Measures

Name	Time	Method
Implicit memory	Approximately 24 hours after surgery	Implicit memory will be investigated using free association test: patients, during maintenance of anesthesia, will listen a piece of one of two stories, "Puss in Boots" or "Pinocchio", each followed by four keywords. Approximately 24 hours after surgery, patients will be asked to associate the first thing that comes to mind with these keywords in order to highlight the presence of implicit memory. The test will be repeated twice and will be positive if the patient will reply with the title of the story or a word of it.

Secondary Outcome Measures

Name	Time	Method
Dreams recall	Approximately 24 hours after anaesthesia	Patients will be asked again about dreams recall. The content of dreams will be analyzed using the 5-point Likert scales which contains the following dreams characteristics: memory content, emotional content, emotional intensity, vivid description, amount of sounds, meaning, how much movement, strange, episodic content, references to episodes of life.
Explicit memory	Approximately 24 hours after surgery	Patients will be asked about the last thing they remembered before going to sleep; the first thing they remember when they woke up; and anything which happen in between, including sounds, dreams and imagination.

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy