Memory During Anesthesia: the Role of Stress Hormones

Surgical Procedure, Unspecified Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01146405
• Other study ID #: 918/09
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2010
• Last updated: February 8, 2011
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2009
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

1. To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.

2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.

3. To investigate whether, in patients receiving auditory stimulation, there is a correlation between hormones levels (cortisol+prolactin), serum remifentanil concentration and detection of implicit memory.

4. To investigate the presence of primary auditory cortex activation (temporal lobe) in patients with implicit memory and in those with dreams recall using the EEG-ERP 128 channels GES300 EGI system.

Description:

Patients from group A, during maintenance of anesthesia, at the time of trocar insertion, will listen (via MP3) a piece of one of two stories, "Puss in Boots" and "Pinocchio", each followed by four keywords. In group B, patients will be isolated from the sounds of the operating room using specific headphones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 70 years old

• Class-ASA Physical Status I-II

Exclusion Criteria:

• Psychiatric or neurological disorders and/or hearing disorders

• Obesity (Body Mass Index > 30)

• Drug addiction, alcoholism

• Patients with an education level below middle school

• Patients with difficulty in understanding the Italian language

• Patients treated with corticosteroids and/or estrogens, pregnant patients and patients suffering from hypercorticism

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hormones levels	The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg	No
Primary	Hormones levels	The blood sample will be taken 30 minutes before induction of anaesthesia to determine baseline hormones (cortisol + prolactine) levels.	Baseline	No
Secondary	Remifentanil concentration	One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg	No
Secondary	Memory	Patients will be asked to associate with keywords the first thing that comes them to mind (implicit memory). Also eplicit memory and dreams recall will be tested at the same time. The content of intraoperative dreams (confirmed by a brief post-anesthesia interview) will be analyzed using the 5-point Likert scale.	Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia	No
Secondary	Primary auditory cortex activation	ERP-EEG monitoring system with 128 channel EGI GES300	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg	No