Clinical trial NCT03696719: Anesthetic Method and Cerebral Outcomes
Official title: Anesthetic Method and Cerebral Outcomes: A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Neuron Degeneration
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Research regarding the effects of anesthesia on the central nervous system remain controversial with some studies suggesting a neurotoxic effect and others indicating a neuroprotective effect.

In recent years numerous neuronal proteins have been found to be useful tools for diagnosis and prognosis of cerebral tissue damage. Among these neuronal proteins are the following markers: Neuron Specific Enolase (NSE), Tau protein, Glial Fibrillary Acidic Protein (GFAP), Ubiquitin Carboxy-Hydrolase L1 (UCH-L1).

BIS is a non-invasive brain monitoring technology which monitors the depth of anesthesia.

In this randomized clinical trial, we aim to examine the effect of anesthetic method (General anesthesia and neuroaxial anesthesia) on neuronal damage as measured by NSE serum levels.

One hundred and forty patients aged 18 and above undergoing Transurethral resection of the prostate, Trans Urethral Resection of the Bladder Tumor, Tension Free Vaginal Tap , Trans Obturator Tension Free Vaginal Tap and pelvic floor repair surgeries will be enrolled in the study.

Patients will randomly be assigned to undergo the study either under general anesthesia or with neuroaxial anesthesia.

Participants will be monitored using the BIS monitor, to measure the depth of anesthesia.

Additionally, 9 cc of venous blood 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 NSE levels.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

The study will conducted in Beilinson Hospital . All patients above 18 presenting for primary TURP, TURBT, TVT, TVT-O and pelvic floor repair surgeries. All patients who are able to comply with the study requirements and gave a written informed consents.

Exclusion Criteria:

1. Patients with a history of a cerebrovascular accident (CVA) or Transient ischemic attack (TIA) in the year prior to surgery.
2. Patients with significant decreases in cognitive function prior to surgery.
3. Patients presenting for a secondary TURB surgery.
4. Patient with a contraindication to NA.
5. Patients who are unable to sign an informed consent form.

Primary outcomes:
measure: NSE serum level in PACU
timeFrame: 1 hour after surgery completion
Secondary outcomes:
measure: NSE serum levels after anesthesia induction
timeFrame: Half an hour after anesthesia induction
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center/Beilinson Campus
Study officials:
References:
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