An interventional study of Lidocaine IV and Ketamine Injectable Solution in Colorectal (Colon or Rectal) Cancer and Inflammation, sponsored by University Tunis El Manar. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Prevention
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.
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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NON INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous Lidocaine dose loading than continuous infusion
Drug: Lidocaine IV
Intravenous Ketamine dose loading than continuous infusion
Drug: Ketamine Injectable Solution
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
The variation of Interleukin-6 levels
The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.
Time frame: 24 hours after surgery
Pain assessed by Numerical Rating Scale (NRS)
Postoperative pain was assessed by the Numerical Rating Scale (NRS)
Time frame: 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'.
Post-operative nausea and vomiting
Incidence of post-operative nausea and vomiting during the first 24 hours.
Time frame: During the first 24 hours postoperatively
Bowel function.
Time to return of bowel function.
Time frame: During the first 24 hours postoperatively
Hospital length of stay.
Hospital length of stay ( in days)
Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Post-operative complications.
Incidence of intrahospital post-operative complications.
Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Started Oct 2023 (actual). Primary completion is estimated for Feb 2026, 28 months after the start.
Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 28 months is close to that.
Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.
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Studies of the drug tested here: Lidocaine
University Tunis El Manar