Clinical trial
The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial
Name
UTEM ELKI
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-05-30
Trial end
2024-06-30
Status
Recruiting
Treatment
Lidocaine IV
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Arms:
IV-Lido
Ketamine Injectable Solution
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Arms:
IV-Keta
Size
50
Primary endpoint
The variation of Interleukin-6 levels
24 hours after surgery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intravenous Lidocaine vs intravenous ketamine', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-16
1 organization
2 products
2 indications
Organization
University of Tunis El ManarProduct
LidocaineIndication
Colorectal CancerIndication
InflammationProduct
Ketamine