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Memory During Anesthesia: the Role of Stress Hormones

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01146405
Enrollment
110
Registered
2010-06-17
Start date
2010-06-30
Completion date
2011-10-31
Last updated
2011-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified

Keywords

Laparoscopic

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.

Interventions

None listed

Sponsors

Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Hormones levels5 minutes after achieving a pneumoperitoneum pressure of 12 mmHgThe blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.

Secondary

MeasureTime frameDescription
Remifentanil concentration5 minutes after achieving a pneumoperitoneum pressure of 12 mmHgOne blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).
MemoryApproximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesiaPatients 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.
Primary auditory cortex activation5 minutes after achieving a pneumoperitoneum pressure of 12 mmHgERP-EEG monitoring system with 128 channel EGI GES300

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026