Clinical trial NCT06272461: Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
Official title: The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal (Colon or Rectal) Cancer
Inflammation
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intravenous Lidocaine vs intravenous ketamine
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: The variation of Interleukin-6 levels
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Pain assessed by Numerical Rating Scale (NRS)
timeFrame: 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'.
measure: Post-operative nausea and vomiting
timeFrame: During the first 24 hours postoperatively
measure: Bowel function.
timeFrame: During the first 24 hours postoperatively
measure: Hospital length of stay.
timeFrame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
measure: Post-operative complications.
timeFrame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Tunisia
Study officials:
affiliation: university manar Tunis, Tunisia
name: BEN ALI MECHAAL, Professor
role: PRINCIPAL_INVESTIGATOR
References: