Colorectal (Colon or Rectal) Cancer, Inflammation
Conditions
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.
Interventions
DRUGLidocaine IV
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Intravenous Lidocaine vs intravenous ketamine
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The variation of Interleukin-6 levels | 24 hours after surgery | The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessed by 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'. | Postoperative pain was assessed by the Numerical Rating Scale (NRS) |
| Post-operative nausea and vomiting | During the first 24 hours postoperatively | Incidence of post-operative nausea and vomiting during the first 24 hours. |
| Bowel function. | During the first 24 hours postoperatively | Time to return of bowel function. |
| Hospital length of stay. | From date of randomization until the date of to discharge from the hospital assessed up to 15 days | Hospital length of stay ( in days) |
| Post-operative complications. | From date of randomization until the date of to discharge from the hospital assessed up to 15 days | Incidence of intrahospital post-operative complications. |
Countries
Tunisia
Contacts
Primary ContactBEN ALI MECHAAL, Professor
Backup ContactKTATA HIBA, Dr
Outcome results
None listed