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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01146431
Enrollment
130
Registered
2010-06-17
Start date
2010-06-30
Completion date
Unknown
Last updated
2011-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

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.

Interventions

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).

Sponsors

Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implicit memoryApproximately 24 hours after surgeryImplicit 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

MeasureTime frameDescription
Dreams recallApproximately 5 minutes after awakening from anesthesiaA first interview about dreams recall will be carried out 5 minutes after awakening from anesthesia. Patients will be asked about dream content.
Explicit memoryApproximately 24 hours after surgeryPatients 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.

Countries

Italy

Contacts

Primary ContactPaola Aceto, MD
etico@rm.unicatt.it+390630155556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026