Memory During Anesthesia: the Role of Stress Hormones

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Catholic University of the Sacred Heart.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01146405

First received: June 9, 2010

Last updated: February 8, 2011

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 9, 2010
Last Updated Date	February 8, 2011
Start Date ^ICMJE	June 2010
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Hormones levels [ Time Frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg ] [ Designated as safety issue: No ] The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels. Hormones levels [ Time Frame: Baseline ] [ Designated as safety issue: No ] The blood sample will be taken 30 minutes before induction of anaesthesia to determine baseline hormones (cortisol + prolactine) levels.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01146405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Remifentanil concentration [ Time Frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg ] [ Designated as safety issue: No ] One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients). Memory [ Time Frame: Approximately 24 hours after surgery for explicit memory, implicit memory and for dreams recall detected after awakening from anesthesia ] [ Designated as safety issue: No ] 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. Primary auditory cortex activation [ Time Frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg ] [ Designated as safety issue: No ] ERP-EEG monitoring system with 128 channel EGI GES300
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Memory During Anesthesia: the Role of Stress Hormones
Official Title ^ICMJE	Not Provided
Brief 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.
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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Whole blood and serum.
Sampling Method	Probability Sample
Study Population	Patients sheduled for minor elective laparoscopic surgery
Condition ^ICMJE	Surgical Procedure, Unspecified
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	110
Estimated Completion Date	October 2011
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01146405
Other Study ID Numbers ^ICMJE	918/09
Has Data Monitoring Committee	No
Responsible Party	Liliana Sollazzi, Catholic University of Sacred Heart
Study Sponsor ^ICMJE	Catholic University of the Sacred Heart
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Catholic University of the Sacred Heart
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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