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

NCT ID: NCT01146431

Last Updated: 2011-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Brief Summary

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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

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Conditions

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Thyroidectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodynamic parameters

Hemodynamic parameters will be used as a guide for anesthesia.

Inhaled anesthetics

Intervention Type DRUG

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).

BIS

Bispectral Index (BIS) will be used as a guide for anesthesia.

Inhaled anesthetics

Intervention Type DRUG

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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Catholic University of Sacred Heart

Locations

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Catholic University of Sacred Heart

Rome, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Aceto, MD

Role: CONTACT

+390630155556

Other Identifiers

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A/1051/2009

Identifier Type: -

Identifier Source: org_study_id

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