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

Not Applicable

• Conditions: General Surgery
• Interventions: Other: General anesthesia; Other: Hypno-analgesia

• Registration Number: NCT04500236
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

POD and POCD are manifestations of cognitive dysfunction occurring in the perioperative period. Whether surgery and specifically anesthesia contribute to the development of perioperative cognitive dysfunctions is not clear.

Cell culture and animal studies have suggested detrimental effects of anesthetic exposure.1,2,3 Otherwise, it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone.4 Proinflammatory cytokine levels increase during surgery. These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration.5 However, anesthetics may be capable of modulating inflammation and may alter the neuroinflammatory response.

Clinical studies associating the effects of general anesthesia with POCD and POD are conflicting.6 These varying results could be due to heterogeneity of patients' baseline status (e.g. cognitive status, education, associated diseases), type of surgery, as well as methods used to determine POCD and POD.

The use of serum neurobiomarkers, sensitive and specific for neuronal cell injury will address the hypothesis of general anesthesia neurotoxicity. Serum Neurofilament Light (NFL) is such a neurobiomarker.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. Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia (GA)	General anesthesia	Patients undergoing thyroid or breast cancer surgery under general anesthesia
Hypno-analgesia (Hyp)	Hypno-analgesia	Patients undergoing thyroid or breast cancer surgery under Hypno-analgesia; i.e.hypnosis combined with the use of analgesics.

Primary Outcome Measures

Name	Time	Method
Serum Neurofilament Light at first postoperative day (18 - 24 hours) postoperatively) between both groups	18 hours to 24 hours postoperatively	Comparison of postoperative serum Neurofilament Light between both groups

Secondary Outcome Measures

Name	Time	Method
Total postoperative analgesic consumption between both groups	24 hours postoperatively	Comparison of total consumed analgesics in the postoperative period
Postoperative serum Neurofilament Light at postoperative day 8 - 10	Day 8 to day 10	Analysis of postoperative serum Neurofilament Light between both groups
Comparison of postoperative Montreal Cognitive Assessment on a scale of 30 (higher scores are better) between both groups	Day 8 to day 10	Postoperative Montreal Cognitive Assessment
Quality of Recovery F15 questionnaire with 15 questions on a scale of 10 (higher scores are better) between both groups	Day 8 to day 10	Comparison of quality of recovery between both groups based on a validated questionnaire with 15 items
Postoperative C-reactive protein between both groups	24 hours postoperatively	Comparison of postoperative highest C-reactive protein between both groups
Postoperative serum Neurofilament Light in function of type of surgery	24 hours postoperatively	Analysis of postoperative serum Neurofilament Light in function of type of surgery

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium