Anesthetic Method and Cerebral Outcomes

NCT03696719 | Unknown

• 1 other identifier: 616-18
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Neuron Degeneration

Outcome Measures

Primary Outcomes (1)

• NSE serum level in PACU

  1 hour after surgery completion

Secondary Outcomes (1)

• NSE serum levels after anesthesia induction

  Half an hour after anesthesia induction

Study Arms (2)

Undergoing surgery under general anesthesia

ACTIVE COMPARATOR

Patients will undergo the surgery under general anesthesia, anesthetic regime will be according to standard clinical practice.

Device: BIS bispectral index monitoring device; Biological: NSE cerebral biomarker testing

Undergoing surgery under regional anesthesia

ACTIVE COMPARATOR

Patients will undergo the surgery under neuroaxial anesthesia.

Biological: NSE cerebral biomarker testing

Interventions

BIS bispectral index monitoring device 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.

Undergoing surgery under general anesthesia

NSE cerebral biomarker testing BIOLOGICAL

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.

Undergoing surgery under general anesthesia; Undergoing surgery under regional anesthesia

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center/Beilinson Campus

Petah Tikva, 49100, Israel

Location

Related Publications (11)

• Evered L, Silbert B, Scott DA, Zetterberg H, Blennow K. Association of Changes in Plasma Neurofilament Light and Tau Levels With Anesthesia and Surgery: Results From the CAPACITY and ARCADIAN Studies. JAMA Neurol. 2018 May 1;75(5):542-547. doi: 10.1001/jamaneurol.2017.4913.

  PMID: 29459944 BACKGROUND

• Cata JP, Abdelmalak B, Farag E. Neurological biomarkers in the perioperative period. Br J Anaesth. 2011 Dec;107(6):844-58. doi: 10.1093/bja/aer338. Epub 2011 Nov 6.

  PMID: 22065690 BACKGROUND

• Tomaszewski D. Biomarkers of Brain Damage and Postoperative Cognitive Disorders in Orthopedic Patients: An Update. Biomed Res Int. 2015;2015:402959. doi: 10.1155/2015/402959. Epub 2015 Aug 31.

  PMID: 26417595 BACKGROUND

• Trakas E, Domnina Y, Panigrahy A, Baust T, Callahan PM, Morell VO, Munoz R, Bell MJ, Sanchez-de-Toledo J. Serum Neuronal Biomarkers in Neonates With Congenital Heart Disease Undergoing Cardiac Surgery. Pediatr Neurol. 2017 Jul;72:56-61. doi: 10.1016/j.pediatrneurol.2017.04.011. Epub 2017 Apr 21.

  PMID: 28571730 BACKGROUND

• van Munster BC, Korse CM, de Rooij SE, Bonfrer JM, Zwinderman AH, Korevaar JC. Markers of cerebral damage during delirium in elderly patients with hip fracture. BMC Neurol. 2009 May 27;9:21. doi: 10.1186/1471-2377-9-21.

  PMID: 19473521 BACKGROUND

• Rappold T, Laflam A, Hori D, Brown C, Brandt J, Mintz CD, Sieber F, Gottschalk A, Yenokyan G, Everett A, Hogue CW. Evidence of an association between brain cellular injury and cognitive decline after non-cardiac surgery. Br J Anaesth. 2016 Jan;116(1):83-9. doi: 10.1093/bja/aev415.

  PMID: 26675953 BACKGROUND

• Li YN, Zhang Q, Yin CP, Guo YY, Huo SP, Wang L, Wang QJ. Effects of nimodipine on postoperative delirium in elderly under general anesthesia: A prospective, randomized, controlled clinical trial. Medicine (Baltimore). 2017 May;96(19):e6849. doi: 10.1097/MD.0000000000006849.

  PMID: 28489775 BACKGROUND

• Yokobori S, Hosein K, Burks S, Sharma I, Gajavelli S, Bullock R. Biomarkers for the clinical differential diagnosis in traumatic brain injury--a systematic review. CNS Neurosci Ther. 2013 Aug;19(8):556-65. doi: 10.1111/cns.12127. Epub 2013 May 27.

  PMID: 23710877 BACKGROUND

• Feng F, Chen Z, Cromer J, Doerr A, Glow A, Horstman-Reser A, Infanger A, Lovas E, Ryberg J, Sinclair M, Zecy A. Anesthetic Concerns for Patients Undergoing a Transurethral Resection of the Prostate (TURP). Urol Nurs. 2016 Mar-Apr;36(2):75-81.

  PMID: 27281864 BACKGROUND

• Jang D, Lim CS, Shin YS, Ko YK, Park SI, Song SH, Kim BJ. A comparison of regional and general anesthesia effects on 5 year survival and cancer recurrence after transurethral resection of the bladder tumor: a retrospective analysis. BMC Anesthesiol. 2016 Mar 12;16:16. doi: 10.1186/s12871-016-0181-6.

  PMID: 26971194 BACKGROUND

• Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Prophet N, Purushothaman B, Green D. Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial. PLoS One. 2012;7(6):e37410. doi: 10.1371/journal.pone.0037410. Epub 2012 Jun 15.

  PMID: 22719840 BACKGROUND

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

IL (1)