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Trial Title:
Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
NCT ID:
NCT06272461
Condition:
Colorectal (Colon or Rectal) Cancer
Inflammation
Conditions: Official terms:
Inflammation
Lidocaine
Ketamine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Intravenous Lidocaine vs intravenous ketamine
Primary purpose:
Prevention
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Lidocaine IV
Description:
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Arm group label:
IV-Lido
Intervention type:
Drug
Intervention name:
Ketamine Injectable Solution
Description:
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Arm group label:
IV-Keta
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tunisia
Address:
City:
Nabeul
Zip:
8000
Country:
Tunisia
Status:
Recruiting
Contact:
Last name:
BEN ALI MECHAAL
Phone:
53890987
Phone ext:
00216
Email:
mechaal_benali@yahoo.fr
Start date:
October 1, 2023
Completion date:
January 30, 2025
Lead sponsor:
Agency:
University Tunis El Manar
Agency class:
Other
Source:
University Tunis El Manar
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06272461
