General Surgery
Conditions
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.
Interventions
OTHERGeneral anesthesia
Surgery under general anesthesia with the use of propofol
OTHERHypno-analgesia
Surgery under Hypnosis session and analgesics
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative analgesic consumption between both groups | 24 hours postoperatively | Comparison of total consumed analgesics in the postoperative period |
| 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 |
| Postoperative serum Neurofilament Light at postoperative day 8 - 10 | Day 8 to day 10 | Analysis of postoperative serum Neurofilament Light between both groups |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frontal EEG analysis of patients under hypnosis | Intraoperatively | Analysis of raw frontal EEG power (in slow, delta, theta, alpha, beta and gamma band) from the depth-of-anesthesia monitor as a sub-analysis of this study |
Countries
Belgium
Contacts
Primary ContactMona Momeni, MD, PhD
Outcome results
None listed