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Clinical Trials/NCT01146405
NCT01146405UnknownNot Applicable

Memory During Anesthesia: the Role of Stress Hormones

Catholic University of the Sacred Heart1 site in 1 country110 target enrollmentStarted: June 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
110
Locations
1
Primary Endpoint
Hormones levels
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Hormones levels

Time Frame: Baseline

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

Secondary Outcomes

  • Remifentanil concentration(5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg)
  • Primary auditory cortex activation(5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg)
  • Memory(Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia)

Investigators

Sponsor Class
Other

Study Sites (1)

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