Anesthetic Method and Cerebral Outcomes

I

Specific Aim:

Primary Endpoint Our primary endpoint is to compare the effect of anesthetic method (GA vs. NA) on plasma level of neuronal damage biomarker NSE.

Study Design:

This is a prospective, single center, randomized controlled trial that try to assess the effect of anesthetic method on neuronal damage biomarker level. The study will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital.

One hundred and forty patients aged 18 and above, undergoing elective TURB, TURBT, (TVT-O) and pelvic floor repair surgeries, will be enrolled in the study following providing their consent for participation.

Index procedure:

After consenting to participation patients will be randomly assigned to one of the following study groups:

1. Patients undergoing surgery under GA

2. Patients undergoing surgery with NA. Anesthetic regime will be subject to standard clinical guidelines and to clinical judgement of the attending anesthesiologist.

Intraoperative and postoperative hemodynamic monitoring will be according to standard departmental and clinical guidelines. Data will be recorded and stored electronically by Metavision system (iMDsoft company).

BIS monitoring:

In addition to the standard monitoring prescribed by the American society of Anesthesiologists, all study participants will be monitored with the BIS, a noninvasive monitoring device which measures the depth of anesthesia. The monitoring is performed using noninvasive electrodes placed on the forehead.

Blood tests:

Venous blood will be collected from each participant in the surgery room prior to anesthesia induction, throughout anesthesia and one hour following surgery in the PACU in order to assess cerebral biomarkers according to the ELISA method requirements. At each one of the assessment points 9 cc of venous of blood will be taken from each of the study participants, while routine blood tests are taken.

Data Collection

For each participating patient the following data will be collected and recorded through the study duration:

1. Demographic data

2. Each participant medical history including concomitant medications.

3. Hemodynamic data including heart rate, automatic non-invasive blood pressure measurements, temperature as well pulse oximetry as routine procedures will be recorded and stored by Metavision system.

4. Anesthetic data: anesthetic method, anesthetic agents given throughout surgery, anesthetic complications.

5. Opioid use in the first 24 hours after surgery.

6. Duration of stay in the PACU.

7. Duration of hospital stay

8. Functional status upon hospital release.