Status unknownNCT01146405Updated Feb 9, 2011

Memory During Anesthesia: the Role of Stress Hormones

An observational study in Surgical Procedure, Unspecified, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-02-09.

Sponsored by Catholic University of the Sacred Heart · Observational

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 110
Ages: 18 Years to 70 Years
Sex: All

Study summary

To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.
To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.
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.
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.

Read the 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.

Conditions studied

Surgical Procedure, Unspecified

Keywords

Laparoscopic

In context

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patients sheduled for minor elective laparoscopic surgery

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Inclusion criteria

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

Exclusion criteria

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
Enrollment: 110 participants (estimated)
Biospecimen retention: Samples without dna

What researchers measure

Primary outcomes

Hormones levels
The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.
Time frame: 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.
Time frame: Baseline

Secondary outcomes

Remifentanil concentration
One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).
Time frame: 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.
Time frame: 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
Time frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg

Study locations

1 of 1 sites recruiting

Catholic University of Sacred Heart
Rome, Italy
- Paola Aceto, MD · Contact · etico@rm.unicatt.it
- Liliana Sollazzi, Associate Professor · Principal investigator
- Paola Aceto, MD · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01146405
Lead sponsor: Catholic University of the Sacred Heart
First posted: Jun 17, 2010
Start date: Jun 2010
Primary completion: Oct 2011 (estimated)
Completion: Oct 2011 (estimated)
Last update: Feb 9, 2011

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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