This study examines if remote ischemic preconditioning in patients undergoing minor acute abdominal surgery (laparoscopic cholecystitis due to acute cholecystitis) is associated with a modulation of endothelial dysfunction. half of the patients will receive remote ischemic preconditioning prior to surgery, the other half will serve as controls.
Remote ischemic preconditioning (RIPC) consists of cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods. The procedure is simple, safe and with no clear side effects. In clinical studies covering acute cardiology RIPC has effectively reduced myocardial injury, postoperative cardiovascular complications and cardiac mortality. Recently, the effect of RIPC on attenuating ischemia-reperfusion injury has been investigated in non-cardiac surgery as well. The organ specific ischemia-reperfusion injury, systemic oxidative stress and inflammatory response were attenuated due to the intervention but a complete understanding of the underlying protective mechanisms of RIPC is however still lacking. Experimental and clinical studies have implicated that the stimulus of RIPC is transmitted from the preconditioned tissue to other tissues and organs by humoral, neural and systemic anti-inflammatory mediators. The humoral and neural pathway are thought to be dependent on endogen substances such as adenosine, bradykinin, nitrogen oxide (NO) and calcitonin-gene-related-peptide (CGRP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods
Center for Surgical Science, Surgical Department, Zealand University Hospital
Køge, Region Sjælland, Denmark
Changes in endothelial function measured by reactive hyperemia index (RHI)
Changes in endothelial function measured by reactive hyperemia index (RHI) at baseline, four hours and 24 hours after surgery (cholecystectomy due to acute cholecystitis)
Time frame: 24 hours
Heart rate variability
Changes in Heart rate variability measured with eMotion Faros from baseline and 24 hours consecutively.
Time frame: 24 hours
Changes in p-L-arginine
Changes in p-L-arginine in μmol/L from baseline til 24h post-surgery
Time frame: 24 hours
Changes in p-asymmetric dimethylarginine
Changes in p-asymmetric dimethylarginine in μmol/L from baseline til 24h post-surgery
Time frame: 24 hours
Changes in p-biopterins
Changes in p-biopterins in ng/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in soluble endothelial (E-) selectin
Changes in soluble E-selectin in ng/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in soluble plasma (P-) selectin
Changes in soluble P-selectin in ng/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in Intercellular Adhesion Molecule 1 (ICAM-1)
Changes in soluble Intercellular Adhesion Molecule 1 (ICAM-1) in ng/ml from baseline til 24h post-surgery
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Time frame: 24 hours
Changes in syndecan-1
Changes in syndecan-1 in pg/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in thrombomodulin
Changes in thrombomodulin in pg/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in arginine vasopressin
Changes in arginine vasopressin in ng/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in adrenalin
Changes in adrenalin in ng/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in noradrenalin
Changes in noradrenalin in pg/ml from baseline til 24h post-surgery
Time frame: 24 hours
Changes in ascorbic acid
Changes in ascorbic acid in ng/μL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in dehydroascorbic acid
Changes in dehydroascorbic acid in ng/μL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in angiotensin II
Changes in angiotensin II in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in bradykinin
Changes in bradykinin in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in calcitonin-gene related peptide
Changes in calcitonin-gene related peptide in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in prostacyclin
Changes in prostacyclin in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in serotonin
Changes in serotonin in ng/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in endothelin-1
Changes in endothelin-1 in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in adrenomedullin
Changes in adrenomedullin in ng/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in platelets
Changes in platelets x 109/L from baseline til 24h post-surgery
Time frame: 24 hours
Changes in adenosin
Changes in adenosin μmol/L from baseline til 24h post-surgery
Time frame: 24 hours
Changes in interleukin-6(IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-alpha), transforming growth factor beta (TGF-beta)
Changes in IL-6, IL-10, TNF-Alpha, TGF-beta in pg/mL from baseline til 24h post-surgery
Time frame: 24 hours
Changes in gene expression autoimmune human pathway panel from NanoString
Changes in gene expression profiles in the autoimmune human pathway panel from NanoString from baseline until four hours post-surgery.
Time frame: 4 hours
Local complications to RIPC
Pain, changed sensibility or decreased function of the upper extremity where remote ischemic preconditioning were carried out preoperatively.
Time frame: 24 hours
Differences in postoperative quality of recovery score 15 (QoR-15) between arms in the trial
Questionnaire on Postoperative quality of recovery with 15 questions comparing scores from baseline, 24 hours and 30 days after surgery between study arms (intervention and controls)
Time frame: 30 days
Differences in Self reported pain on a 0-10 scale between arms in the trial
Self reported pain on a 0-10 scale at baseline and 24 hours after surgery between study arms (intervention and controls)
Time frame: 24 hours