The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

NCT03821545 | Completed

• 1 other identifier: Ostovic
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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; 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.

Conditions

Colorectal Cancer

Keywords

Anti-Inflammatory Effect; Surgical Stress; Lidocaine; Ketamine; Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Concentration of inflammatory markers

  Measuring of inflammatory markers in serum (CRP, IL-6, IL-8) before induction of anesthesia, then 12 hours and 36 hours following the completion of surgery

  1-2 days

Secondary Outcomes (5)

• Opioid consumption during anesthesia

  1 day

• VAS- scores

  2 days

• Analgesic consumption

  2 days

• Recovery of bowel function

  1-5 days

• Length of hospital stay

  1- 30 days

Study Arms (4)

Lidocaine Group

ACTIVE COMPARATOR

Other: Lidocaine

Ketamine Group

ACTIVE COMPARATOR

Other: Ketamine

Lidocaine and Ketamine Group

ACTIVE COMPARATOR

Other: Lidocaine and Ketamine

Placebo (0.9% NaCl) Group

PLACEBO COMPARATOR

Other: Placebo (0.9% NaCl)

Interventions

Lidocaine OTHER

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.

Lidocaine Group

Ketamine OTHER

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.

Ketamine Group

Lidocaine and Ketamine OTHER

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 and Ketamine Group

Placebo (0.9% NaCl) OTHER

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.

Placebo (0.9% NaCl) Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

Zagreb, 10000, Croatia

Location

Related Publications (1)

• Ostovic H, Simac B, Prazetina M, Bradic N, Persec J. The Effect of Intravenous Lidocaine, Ketamine, and Lidocaine-Ketamine Combination in Colorectal Cancer Surgery: A Randomized Controlled Trial. Anesth Analg. 2025 Jan 1;140(1):67-76. doi: 10.1213/ANE.0000000000006555. Epub 2023 May 24.

  PMID: 37224065 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lidocaine; Ketamine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helena Ostovic MD, Principal Investigator

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 30, 2019
• Study Start: January 28, 2019
• Primary Completion: June 12, 2021
• Study Completion: June 18, 2021
• Last Updated: May 20, 2022

Record last verified: 2020-11

Locations

CR (1)