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

February 8, 2011 updated by: Catholic University of the Sacred Heart
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Catholic University Of Sacred Heart
        • Principal Investigator:
          • Liliana Sollazzi, MD, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing general anesthesia for thyroidectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hemodynamic parameters
Hemodynamic parameters will be used as a guide for anesthesia.
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.
BIS
Bispectral Index (BIS) will be used as a guide for anesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implicit memory
Time Frame: 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.
Approximately 24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dreams recall
Time Frame: Approximately 5 minutes after awakening from anesthesia
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
Explicit memory
Time Frame: 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.
Approximately 24 hours after surgery
Dreams recall
Time Frame: 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.
Approximately 24 hours after anaesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A/1051/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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