Memory During Anesthesia: the Role of Stress Hormones

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.

Study Overview

• Status: Unknown
• Conditions: Surgical Procedure, Unspecified

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 Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Catholic University Of Sacred Heart
    • Contact: Paola Aceto, MD; Email: etico@rm.unicatt.it
    • Principal Investigator: Liliana Sollazzi, Associate Professor

Participation Criteria

Eligibility Criteria

• 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 sheduled for minor elective laparoscopic surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Primary auditory cortex activation	ERP-EEG monitoring system with 128 channel EGI GES300	5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 9, 2011
• Last Update Submitted That Met QC Criteria: February 8, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Laparoscopic
• Other Study ID Numbers: 918/09