Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Colorectal (Colon or Rectal) Cancer
• Intervention / Treatment: Drug: Lidocaine IV; Drug: Ketamine Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BEN ALI MECHAAL, Professor; Phone Number: 00216 72100533; Email: mechaal_benali@yahoo.fr
• Study Contact Backup: Name: KTATA HIBA, Dr; Phone Number: 00216 72100500; Email: Hibetallah.ktata@fmt.utm.tn

Study Locations

• Tunisia
  • Nabeul, Tunisia, 8000
    • Recruiting
    • Tunisia
    • Contact: BEN ALI MECHAAL; Phone Number: 00216 53890987; Email: mechaal_benali@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV-Lido; Intravenous Lidocaine dose loading than continuous infusion	Drug: Lidocaine IV; Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Active Comparator: IV-Keta; Intravenous Ketamine dose loading than continuous infusion	Drug: Ketamine Injectable Solution; Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The variation of Interleukin-6 levels	The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative nausea and vomiting	Incidence of post-operative nausea and vomiting during the first 24 hours.	During the first 24 hours postoperatively
Bowel function.	Time to return of bowel function.	During the first 24 hours postoperatively
Hospital length of stay.	Hospital length of stay ( in days)	From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Post-operative complications.	Incidence of intrahospital post-operative complications.	From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Pain assessed by Numerical Rating Scale (NRS)	Postoperative pain was assessed by the Numerical Rating Scale (NRS)	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'.

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: BEN ALI MECHAAL, Professor, university manar Tunis, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Lidocaine
• Other Study ID Numbers: UTEM ELKI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No