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NCT Number: NCT06272461

Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tunisia

Nabeul, 8000, Tunisia

Location status: Recruiting

Location contact

BEN ALI MECHAAL

CONTACT

[email protected]

53890987 ext. 00216

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine IV

Drug

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Ketamine Injectable Solution

Drug

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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'.

    Postoperative pain was assessed by the Numerical Rating Scale (NRS)

  2. Post-operative nausea and vomiting

    Time frame: During the first 24 hours postoperatively

    Incidence of post-operative nausea and vomiting during the first 24 hours.

  3. Bowel function.

    Time frame: During the first 24 hours postoperatively

    Time to return of bowel function.

  4. Hospital length of stay.

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

    Hospital length of stay ( in days)

  5. Post-operative complications.

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

    Incidence of intrahospital post-operative complications.

Study contacts

Contact information is provided by the study sponsor or research team.

BEN ALI MECHAAL, Professor

CONTACT

[email protected]

72100533 ext. 00216

KTATA HIBA, Dr

CONTACT

[email protected]

72100500 ext. 00216

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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