Serum Neurofilament Light (NFL) in Surgery Under General Anaesthesia (GA) Compared to Surgery With Hypno-analgesia (Hyp)

NCT04500236 | Unknown DMC

• 1 other identifier: 2020/14MAI/273
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental studies have shown that inhalational anesthetics may be neurotoxic by for example causing amyloid beta deposition. Otherwise a pre-clinical study reported an increase in tau phosphorylation with the use of propofol. Whether anesthesia and surgery contribute to the development of long-term cognitive decline remains however controversial. A meta-analysis concluded that general anesthesia could increase the risk of postoperative cognitive decline (POCD) compared with regional or combined anesthesia but this was not shown for Postoperative delirium (POD). This conclusion should be interpreted with caution as these studies showed many shortcomings. Currently no study has compared the release of Neurofilament Light, a biomarker of neuronal injury, in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs.

Conditions

General Surgery

Outcome Measures

Primary Outcomes (1)

• Serum Neurofilament Light at first postoperative day (18 - 24 hours) postoperatively) between both groups

  Comparison of postoperative serum Neurofilament Light between both groups

  18 hours to 24 hours postoperatively

Secondary Outcomes (6)

• Total postoperative analgesic consumption between both groups

  24 hours postoperatively

• Postoperative C-reactive protein between both groups

  24 hours postoperatively

• Postoperative serum Neurofilament Light in function of type of surgery

  24 hours postoperatively

• Comparison of postoperative Montreal Cognitive Assessment on a scale of 30 (higher scores are better) between both groups

  Day 8 to day 10

• Postoperative serum Neurofilament Light at postoperative day 8 - 10

  Day 8 to day 10

Other Outcomes (1)

• Frontal EEG analysis of patients under hypnosis

  Intraoperatively

Study Arms (2)

General Anesthesia (GA)

ACTIVE COMPARATOR

Patients undergoing thyroid or breast cancer surgery under general anesthesia

Other: General anesthesia

Hypno-analgesia (Hyp)

PLACEBO COMPARATOR

Patients undergoing thyroid or breast cancer surgery under Hypno-analgesia; i.e.hypnosis combined with the use of analgesics.

Other: Hypno-analgesia

Interventions

General anesthesia OTHER

Surgery under general anesthesia with the use of propofol

General Anesthesia (GA)

Hypno-analgesia OTHER

Surgery under Hypnosis session and analgesics

Hypno-analgesia (Hyp)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing thyroid or breast cancer surgery and necessitating one night of hospital stay

You may not qualify if:

• Renal insufficiency with a GFR \< 30 mL/min
• Mammectomy
• Preoperative psychiatric problems
• Patients not speaking fluently French
• Patients at risk of postoperative hyperalgesia (Kalkman score \> 4/15)
• Allergy to local anesthetics, NSAID and to Rocuronium
• Patients undergoing one day surgery

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (6)

• Whittington RA, Virag L, Marcouiller F, Papon MA, El Khoury NB, Julien C, Morin F, Emala CW, Planel E. Propofol directly increases tau phosphorylation. PLoS One. 2011 Jan 31;6(1):e16648. doi: 10.1371/journal.pone.0016648.

  PMID: 21304998 BACKGROUND

• Eckenhoff RG, Johansson JS, Wei H, Carnini A, Kang B, Wei W, Pidikiti R, Keller JM, Eckenhoff MF. Inhaled anesthetic enhancement of amyloid-beta oligomerization and cytotoxicity. Anesthesiology. 2004 Sep;101(3):703-9. doi: 10.1097/00000542-200409000-00019.

  PMID: 15329595 BACKGROUND

• Wei H, Xie Z. Anesthesia, calcium homeostasis and Alzheimer's disease. Curr Alzheimer Res. 2009 Feb;6(1):30-5. doi: 10.2174/156720509787313934.

  PMID: 19199872 BACKGROUND

• Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.

  PMID: 17325501 BACKGROUND

• Riedel B, Browne K, Silbert B. Cerebral protection: inflammation, endothelial dysfunction, and postoperative cognitive dysfunction. Curr Opin Anaesthesiol. 2014 Feb;27(1):89-97. doi: 10.1097/ACO.0000000000000032.

  PMID: 24300462 BACKGROUND

• Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.

  PMID: 20858956 BACKGROUND

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Mona Momeni, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Momeni, MD, PhD

CONTACT

003227647029; mona.momeni@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)