NCT06272461

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

January 19, 2024

Last Update Submit

November 15, 2025

Conditions

Colorectal (Colon or Rectal) CancerInflammation

Outcome Measures

Primary Outcomes (1)

  • The variation of Interleukin-6 levels

    The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.

    24 hours after surgery

Secondary Outcomes (5)

  • 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'.

  • Post-operative nausea and vomiting

    During the first 24 hours postoperatively

  • Bowel function.

    During the first 24 hours postoperatively

  • Hospital length of stay.

    From date of randomization until the date of to discharge from the hospital assessed up to 15 days

  • Post-operative complications.

    From date of randomization until the date of to discharge from the hospital assessed up to 15 days

Study Arms (2)

IV-Lido

EXPERIMENTAL

Intravenous Lidocaine dose loading than continuous infusion

Drug: Lidocaine IV

IV-Keta

ACTIVE COMPARATOR

Intravenous Ketamine dose loading than continuous infusion

Drug: Ketamine Injectable Solution

Interventions

Lidocaine IVDRUG

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

IV-Lido
Ketamine Injectable SolutionDRUG

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

IV-Keta

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Severe intraoperative complications.
  • Duration of surgery longer than 5 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunisia

Nabeul, 8000, Tunisia

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsInflammation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • BEN ALI MECHAAL, Professor

    university manar Tunis, Tunisia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BEN ALI MECHAAL, Professor

CONTACT

72100533mechaal_benali@yahoo.fr

KTATA HIBA, Dr

CONTACT

72100500Hibetallah.ktata@fmt.utm.tn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intravenous Lidocaine vs intravenous ketamine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 22, 2024

Study Start

October 1, 2023

Primary Completion

February 10, 2026

Study Completion

March 30, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

TU(1)