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The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

U

University Hospital Dubrava

Status

Completed

Conditions

Colorectal Cancer

Treatments

Other: Lidocaine and Ketamine
Other: Lidocaine
Other: Ketamine
Other: Placebo (0.9% NaCl)

Study type

Interventional

Funder types

Other

Identifiers

NCT03821545
Ostovic

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elective Surgery
  • Expected duration of the operation > 2 hours

Exclusion criteria

  • Patients ≤ 18 years of age
  • Patients with history of allergy to local anesthetics
  • Chronic opioid analgesic
  • Patients who are unwilling or unable to participate

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 4 patient groups, including a placebo group

Lidocaine Group
Active Comparator group
Treatment:
Other: Lidocaine
Ketamine Group
Active Comparator group
Treatment:
Other: Ketamine
Lidocaine and Ketamine Group
Active Comparator group
Treatment:
Other: Lidocaine and Ketamine
Placebo (0.9% NaCl) Group
Placebo Comparator group
Treatment:
Other: Placebo (0.9% NaCl)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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