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The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03821545
Recruitment Status : Unknown
Verified April 2019 by Helena Ostovic, University Hospital Dubrava.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Helena Ostovic, University Hospital Dubrava

Tracking Information
First Submitted Date  ICMJE December 28, 2018
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date January 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • LOS [ Time Frame: 1-5 days ]
    Length of stay in the ICU
  • Length of Hospital Stay [ Time Frame: 1-30 days ]
  • Cost of Hospitalisation [ Time Frame: 1-30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Change in opioid administration [ Time Frame: 1 day ]
    Measuring of total opioid consumption during postoperative period
  • Concentration of proinflammatory markers [ Time Frame: 1-2 days ]
    Measuring of proinflammatory markers in serum (CRP, IL-6, IL-8) before induction of anesthesia, then 12 hours and 36 hours following the completion of surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery
Official Title  ICMJE The Immunomodulatory Effects of Ketamine and Lidocaine in Abdominal Surgery: Double-Blind, Placebo-Controlled Clinical Study
Brief 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; LOS in the ICU and LOHS; reduced administration of opioids; reduction of total treatment costs; recovery time between participants undergoing conventional and laparoscopic resection of the colon.

A double-blind, placebo-controlled study will include 120 patients: 60 undergoing conventional and 60 undergoing laparoscopic resection of the colon. 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.

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 invetigators will measure 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Other: Lidocaine
    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.
  • Other: Ketamine
    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.
  • Other: Lidocaine and Ketamine
    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.
  • Other: Placebo (0.9% NaCl)
    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.
Study Arms  ICMJE
  • Active Comparator: Lidocaine Group
    Intervention: Other: Lidocaine
  • Active Comparator: Ketamine Group
    Intervention: Other: Ketamine
  • Active Comparator: Lidocaine and Ketamine Group
    Intervention: Other: Lidocaine and Ketamine
  • Placebo Comparator: Placebo (0.9% NaCl) Group
    Intervention: Other: Placebo (0.9% NaCl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 27, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 7, 2020
Estimated Primary Completion Date January 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821545
Other Study ID Numbers  ICMJE Ostovic
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helena Ostovic, University Hospital Dubrava
Study Sponsor  ICMJE University Hospital Dubrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Dubrava
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP