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The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT03821545
Recruitment Status : 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

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.


Condition or disease Intervention/treatment Phase
Colon Cancer Other: Lidocaine Other: Ketamine Other: Lidocaine and Ketamine Other: Placebo (0.9% NaCl) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Immunomodulatory Effects of Ketamine and Lidocaine in Abdominal Surgery: Double-Blind, Placebo-Controlled Clinical Study
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : January 7, 2020
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine Group 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.

Active Comparator: Ketamine Group 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.

Active Comparator: Lidocaine and Ketamine Group 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.

Placebo Comparator: Placebo (0.9% NaCl) Group 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.




Primary Outcome Measures :
  1. LOS [ Time Frame: 1-5 days ]
    Length of stay in the ICU

  2. Length of Hospital Stay [ Time Frame: 1-30 days ]
  3. Cost of Hospitalisation [ Time Frame: 1-30 days ]

Secondary Outcome Measures :
  1. Change in opioid administration [ Time Frame: 1 day ]
    Measuring of total opioid consumption during postoperative period

  2. 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



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821545


Locations
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Croatia
The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava
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Responsible Party: Helena Ostovic, Helena Ostovic MD, Principal Investigator, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT03821545    
Other Study ID Numbers: Ostovic
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helena Ostovic, University Hospital Dubrava:
Anti-Inflammatory Effect
Surgical Stress
Lidocaine
Ketamine
Abdominal Surgery
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents