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Recruiting NCT06272461

Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

No phase Interventional Colorectal (Colon or Rectal) Cancer Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine IV, Ketamine Injectable Solution.
Who it may be relevant to
Registry conditions: Colorectal (Colon or Rectal) Cancer, Inflammation. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tunisia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial

Overview

Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta). For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours. For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours. Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.

Detailed description

Patients undergoing open colorectal surgery with tumor resection were randomised prospectively into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group (n=25), patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 1.5 mg/kg/h over twenty-four hours.

For the IV-Keta goup(n=25), patients received a loading dose of 0.15mg/kg of Ketamine than a continuous injection of 0.15 mg/kg/h of Ketamine over twenty-four hours.

For both groups, plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. Plasma IL-6 concentrations at each point were compared between the groups.

Interventions

  • Drug Lidocaine IV
    Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
  • Drug Ketamine Injectable Solution
    Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Primary outcome measures

  • The variation of Interleukin-6 levels [Time frame: 24 hours after surgery]
Secondary outcome measures (5)
  • Pain assessed by Numerical Rating Scale (NRS) [Time frame: Postoperatively, at Hour 2, Hour 12 and Hour 24. the patient asked to circle the number between 0 and 10:"0" usually represents 'no pain at all' whereas "10" represents 'the worst pain ever possible'.]
  • Post-operative nausea and vomiting [Time frame: During the first 24 hours postoperatively]
  • Bowel function. [Time frame: During the first 24 hours postoperatively]
  • Hospital length of stay. [Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days]
  • Post-operative complications. [Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 or older.
  • American society of anesthesiologists' (ASA) physical status of I-III.
  • Elective open colorectal surgery.

NON INCLUSION CRITERIA:

  • Patients with contraindications to lidocaine or ketamine.
  • Corticosteroid therapy within the last 6 months.
  • History of immunosuppressive therapy.
  • History of surgery in the last 3 months.
  • Personal medical history of inflammatory bowel disease.
  • Personal medical history of cardiac arrythmias or conduction disorders.
  • Alcohol or drug abuse.
  • Chronic use of opioids or benzodiazepines.

Exclusion criteria

  • Severe intraoperative complications.
  • Duration of surgery longer than 5 hours.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Tunisia · 1 center
  • Tunisia — Nabeul

Identifiers

NCT: NCT06272461 · UTEM ELKI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗