Surgical Procedure, UnspecifiedNCT01146405
Memory During Anesthesia: the Role of Stress Hormones
An observational study of Surgical Procedure, Unspecified, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients sheduled for minor elective laparoscopic surgery
Who may be able to join
- Age between 18 and 70 years old
- Class-ASA Physical Status I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of Sacred Heart
Rome
Paola Aceto, MD, etico@rm.unicatt.it
Liliana Sollazzi, Associate Professor
About this study
- 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
- Surgical Procedure, Unspecified
- Keywords
- Laparoscopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormones levels
The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Remifentanil concentration
One blood sample will be taken to determine steady state concentration of remifentanil (only in a subset of patients).
Measured: 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.
Measured: 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
Measured: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146405
- Sponsor's protocol ID
- 918/09
- Status last verified
- Oct 2009
- First submitted
- 9 Jun 2010
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory During Anesthesia: the Role of Stress Hormones
- ClinicalTrials.gov ID
- NCT01146405
- Acronym / sponsor ID
- 918/09
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Laparoscopic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients sheduled for minor elective laparoscopic surgery
Key inclusion criteria (2 listed)
- Age between 18 and 70 years old
- Class-ASA Physical Status I-II
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hormones levels
Time frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.
Hormones levels
Time frame: Baseline
The blood sample will be taken 30 minutes before induction of anaesthesia to determine baseline hormones (cortisol + prolactine) levels.
3 secondary outcomes
Remifentanil concentration
Time frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
Memory
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
Time frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormones levels (time frame: 5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.