Memory During Anesthesia: the Role of Stress Hormones

NCT01146405 | Unknown

• 1 other identifier: 918/09
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.
2. 2.To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.
3. 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. 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.

Conditions

Surgical Procedure, Unspecified

Keywords

Laparoscopic

Outcome Measures

Primary Outcomes (2)

• Hormones levels

  The blood sample will be taken during anaesthesia to determine intraoperative hormones (cortisol + prolactine) levels.

  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.

  Baseline

Secondary Outcomes (3)

• Remifentanil concentration

  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

• Primary auditory cortex activation

  5 minutes after achieving a pneumoperitoneum pressure of 12 mmHg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients sheduled for minor elective laparoscopic surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 9, 2011

Record last verified: 2009-10

Locations

IT (1)