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

Thyroidectomy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01146431
• Other study ID #: A/1051/2009
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2010
• Last updated: February 8, 2011
• Start date: June 2010

Study information

• Verified date: January 2010
• Source: Catholic University of the Sacred Heart
• Contact: Paola Aceto, MD
• Phone: +390630155556
• Email: etico[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Drug:
• Inhaled anesthetics
Inhaled anaesthetic drugs (sevoflurane or desflurane) concentration will be changed on the basis of hemodynamic parameters (mean arterial pressure and heart rate greater or less than 20% compared to preoperative values).
• Inhaled anesthetics
Inhaled anaesthetic drugs (sevoflurane or desflurane) concentration will be changed on the basis of Bispectral Index (BIS) value which will be maintained between 40 and 50.

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implicit memory	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.	Approximately 24 hours after surgery	No
Secondary	Dreams recall	A first interview about dreams recall will be carried out 5 minutes after awakening from anesthesia. Patients will be asked about dream content.	Approximately 5 minutes after awakening from anesthesia	No
Secondary	Explicit memory	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.	Approximately 24 hours after surgery	Yes
Secondary	Dreams recall	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.	Approximately 24 hours after anaesthesia	No