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Anesthetic Method and Cerebral Outcomes

NCT03696719 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Neuron Degeneration

Interventions

DEVICE

BIS bispectral index monitoring device

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.

BIOLOGICAL

NSE cerebral biomarker testing

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 NSE cerebral biomarker 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.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-11-01
Completion
2021-11-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696719 on ClinicalTrials.gov