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Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

U

University Tunis El Manar

Status

Enrolling

Conditions

Inflammation
Colorectal (Colon or Rectal) Cancer

Treatments

Drug: Ketamine Injectable Solution
Drug: Lidocaine IV

Study type

Interventional

Funder types

Other

Identifiers

NCT06272461
UTEM ELKI

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

IV-Lido
Experimental group
Description:
Intravenous Lidocaine dose loading than continuous infusion
Treatment:
Drug: Lidocaine IV
IV-Keta
Active Comparator group
Description:
Intravenous Ketamine dose loading than continuous infusion
Treatment:
Drug: Ketamine Injectable Solution

Trial contacts and locations

1

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Central trial contact

BEN ALI MECHAAL, Professor; KTATA HIBA, Dr

Data sourced from clinicaltrials.gov

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