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

NCT01146431 | Unknown

• 1 other identifier: A/1051/2009
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Dreams recall

  Approximately 5 minutes after awakening from anesthesia

• Explicit memory

  Approximately 24 hours after surgery

• Dreams recall

  Approximately 24 hours after anaesthesia

Study Arms (2)

Hemodynamic parameters

Hemodynamic parameters will be used as a guide for anesthesia.

Drug: Inhaled anesthetics

BIS

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

Drug: Inhaled anesthetics

Interventions

Inhaled anesthetics 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).

Hemodynamic parameters

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing general anesthesia for thyroidectomy

You may qualify if:

• Age between 18 and 70 years
• Class-ASA Physical Status I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, Italy, 00168, Italy

RECRUITING

Central Study Contacts

Paola Aceto, MD

CONTACT

+390630155556; etico@rm.unicatt.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Last Updated: February 9, 2011

Record last verified: 2010-01

Locations

IT (1)