The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Clinical studies have shown that IV administration of anesthetics, lidocaine and ketamine
      with their anti-inflammatory properties, modulates the acute immune response associated with
      surgical tissue injury, and in this manner they are able to reduce postoperative pain.
      Lidocaine has anti-inflammatory effects on polymorphonuclear granulocytes, IL-6 and IL-8
      cytokines, complement component C3a and IL-1ra in serum. Ketamine produces its
      anti-inflammatory effects by reducing CRP and IL-6 in serum and by inhibiting NF-kB, which
      regulates gene transcription responsible for the production of proinflammatory factors.

      Perioperative combinend IV administration of lidocaine and ketamine could have a more
      favorable anti-inflammatory effect compared to anesthetic given alone or with placebo.

      To investigate the effects of lidocaine and ketamine in patients undergoing abdominal surgery
      on: acute immune response following the level of proinflammatory factors in serum (CRP, IL-6,
      IL-8); postoperative pain management; recovery of bowel function; administration of opioids;
      reduction of total treatment costs; length of hospital stay (LOHS)

      A double-blind, placebo-controlled study will include 100 patients undergoing open colorectal
      surgery. Patients will be randomly assigned to one of four groups: lidocaine, ketamine,
      lidocaine-ketamine, and placebo. Lidocaine will be administered at a dose of 1.5 mg/kg prior
      to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of
      surgery. Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical
      incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery.
      Bolus and continuous placebo infusion (0.9% NaCl) will be equally administered at the same
      dose as the aforementioned anesthetics until the end of the surgery.

      Proinflammatory markers in serum (CRP, IL-6, IL-8) will be measured before induction of
      anesthesia, then 12 hours and 36 hours following the completion of surgery. The intensity of
      pain will be measured using the VAS score 2 hours and 4 hours following surgery and every 12
      hours the following days. The investigators will measure also the consumption of opioids
      during and after surgery, the length of stay in the ICU, where pain control and analgesics
      use will be measured, as well as recovery of bowel function.
    


Intervention name(s): Lidocaine; Ketamine; Lidocaine and Ketamine; Placebo (0.9% NaCl)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery.; Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery.; Lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery. Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery.; Bolus and continuous placebo infusion (0.9% NaCl) will be equally administered at the same dose as the aforementioned anesthetics until the end of the surgery.
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Anti-Inflammatory Effect; Surgical Stress; Lidocaine; Ketamine; Abdominal Surgery