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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Catholic University of the Sacred Heart.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01146431
First received: June 9, 2010
Last updated: February 8, 2011
Last verified: January 2010
History of Changes

June 9, 2010
February 8, 2011
June 2010
Not Provided
Implicit memory [ Time Frame: Approximately 24 hours after surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01146431 on ClinicalTrials.gov Archive Site
  • Dreams recall [ Time Frame: Approximately 5 minutes after awakening from anesthesia ] [ Designated as safety issue: No ]
    A first interview about dreams recall will be carried out 5 minutes after awakening from anesthesia. Patients will be asked about dream content.
  • Explicit memory [ Time Frame: Approximately 24 hours after surgery ] [ Designated as safety issue: Yes ]
    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.
  • Dreams recall [ Time Frame: Approximately 24 hours after anaesthesia ] [ Designated as safety issue: No ]
    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.
Same as current
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Memory During Inhalation Anesthesia Performed With or Without Bispectral Index (BIS) in Patients Undergoing Thyroidectomy
Not Provided

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients undergoing general anesthesia for thyroidectomy
Thyroidectomy
  • 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).
  • Drug: 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.
  • Hemodynamic parameters
    Hemodynamic parameters will be used as a guide for anesthesia.
    Intervention: Drug: Inhaled anesthetics
  • BIS
    Bispectral Index (BIS) will be used as a guide for anesthesia.
    Intervention: Drug: Inhaled anesthetics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
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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
Both
18 Years to 70 Years
No
Contact: Paola Aceto, MD +390630155556 etico@rm.unicatt.it
Italy
 
NCT01146431
A/1051/2009
Not Provided
Catholic University of Sacred Heart
Catholic University of the Sacred Heart
Not Provided
Not Provided
Catholic University of the Sacred Heart
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP