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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01146405
Other study ID # 918/09
Secondary ID
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


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
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