Memory During Anesthesia: the Role of Stress Hormones

• Conditions: Surgical Procedure, Unspecified

• Registration Number: NCT01146405
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2009-10
• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hormones levels	Baseline	The blood sample will be taken 30 minutes before induction of anaesthesia to determine baseline hormones (cortisol + prolactine) levels.

Secondary Outcome Measures

Name	Time	Method
Remifentanil concentration	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg	One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).
Primary auditory cortex activation	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg	ERP-EEG monitoring system with 128 channel EGI GES300
Memory	Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia	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.

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy