Colorectal (Colon or Rectal) CancerNCT06272461
Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
A study testing Lidocaine IV and Ketamine Injectable Solution in people with Colorectal (Colon or Rectal) Cancer and Inflammation, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer, Inflammation
- What is being tested?
- Lidocaine IV and Ketamine Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- Severe intraoperative complications.
- Duration of surgery longer than 5 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Tunisia
Nabeul, 8000
BEN ALI MECHAAL, 53890987 ext. 00216, mechaal_benali@yahoo.fr
About this study
Official title: The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colorectal (Colon or Rectal) Cancer, Inflammation
- Being tested
- Lidocaine IV, Ketamine Injectable Solution
- Medical subject headings
- Colonic Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Ketamine Injectable SolutionDrug
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
| Study group | Role | What they receive |
|---|---|---|
| IV-Lido | Experimental | Intravenous Lidocaine dose loading than continuous infusion Receives: Drug: Lidocaine IV |
| IV-Keta | Active comparator | Intravenous Ketamine dose loading than continuous infusion Receives: Drug: Ketamine Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variation of Interleukin-6 levels
The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.
Measured: 24 hours after surgery
Secondary outcomes (5)
Pain assessed by Numerical Rating Scale (NRS)
Postoperative pain was assessed by the Numerical Rating Scale (NRS)
Measured: 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.
Measured: During the first 24 hours postoperatively
Bowel function.
Time to return of bowel function.
Measured: During the first 24 hours postoperatively
Hospital length of stay.
Hospital length of stay ( in days)
Measured: 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.
Measured: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Oct 2023
- Primary completion10 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intravenous Lidocaine vs intravenous ketamine
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HibetAllah Ktata, University Tunis El Manar
- Investigators
- BEN ALI MECHAAL, Professor, Principal investigator, university manar Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272461
- Sponsor's protocol ID
- UTEM ELKI
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06272461
- Acronym / sponsor ID
- UTEM ELKI
- Conditions
- Colorectal (Colon or Rectal) Cancer, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Intravenous Lidocaine vs intravenous ketamine
| Arm | Type | Receives |
|---|---|---|
| IV-Lido | Experimental | Drug: Lidocaine IVIntravenous Lidocaine dose loading than continuous infusion |
| IV-Keta | Active comparator | Drug: Ketamine Injectable SolutionIntravenous Ketamine dose loading than continuous infusion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged 18 or older.
- American society of anesthesiologists' (ASA) physical status of I-III.
- Elective open colorectal surgery.
- Patients with contraindications to lidocaine or ketamine.
- Corticosteroid therapy within the last 6 months.
Key exclusion criteria (2 listed)
- Severe intraoperative complications.
- Duration of surgery longer than 5 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine IVIntravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer | Drug | IV-Lido |
| Ketamine Injectable SolutionIntravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer | Drug | IV-Keta |
Primary outcome
The variation of Interleukin-6 levels
Time frame: 24 hours after surgery
The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.
5 secondary outcomes
Pain assessed by 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
Time frame: During the first 24 hours postoperatively
Bowel function.
Time frame: During the first 24 hours postoperatively
Hospital length of stay.
Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Post-operative complications.
Time frame: From date of randomization until the date of to discharge from the hospital assessed up to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BEN ALI MECHAAL, Professor principal investigator
university manar Tunis, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine IV and Ketamine Injectable Solution in people with Colorectal (Colon or Rectal) Cancer and Inflammation, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BEN ALI MECHAAL, Professor (72100533 ext. 00216, mechaal_benali@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variation of Interleukin-6 levels (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.