The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Ketamine; Other: Lidocaine; Other: Lidocaine and Ketamine; Other: Placebo (0.9% NaCl)

• Registration Number: NCT03821545
• Lead Sponsor: 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; 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-01-27
• Study Start: 2019-01-28
• Study First Posted: 2019-01-30
• Status Verified: 2020-11
• Primary Completion: 2021-06-12
• Study Completion: 2021-06-18
• Last Update Submitted: 2022-05-14
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	Ketamine	-
Lidocaine Group	Lidocaine	-
Lidocaine and Ketamine Group	Lidocaine and Ketamine	-
Placebo (0.9% NaCl) Group	Placebo (0.9% NaCl)	-

Primary Outcome Measures

Name	Time	Method
Concentration of inflammatory markers	1-2 days	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

Secondary Outcome Measures

Name	Time	Method
Recovery of bowel function	1-5 days	Measuring time to firs bowel movement
Opioid consumption during anesthesia	1 day	Measuring of total opioid consumption during intraoperative period
Length of hospital stay	1- 30 days	Follow-up patients until hospital discharge
Analgesic consumption	2 days	Measuring total analgesic consumption for 48 hours following the completion of surgery
VAS- scores	2 days	Measuring pain scores VAS scores 2 hours and 4 hours following surgery and every 12 hours the following 2 days.

Trial Locations

Locations (1)

The Anti-inflammatory Effect of Anesthetics in Abdominal Surgery; 🇭🇷 Zagreb, Croatia