Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

NCT ID: NCT06272461

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-03-30

Brief Summary

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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

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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

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Colorectal (Colon or Rectal) Cancer Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intravenous Lidocaine vs intravenous ketamine
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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IV-Lido

Intravenous Lidocaine dose loading than continuous infusion

Group Type EXPERIMENTAL

Lidocaine IV

Intervention Type DRUG

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

IV-Keta

Intravenous Ketamine dose loading than continuous infusion

Group Type ACTIVE_COMPARATOR

Ketamine Injectable Solution

Intervention Type DRUG

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Interventions

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Lidocaine IV

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Intervention Type DRUG

Ketamine Injectable Solution

Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Severe intraoperative complications.
* Duration of surgery longer than 5 hours.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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HibetAllah Ktata

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BEN ALI MECHAAL, Professor

Role: PRINCIPAL_INVESTIGATOR

university manar Tunis, Tunisia

Locations

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Tunisia

Nabeul, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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BEN ALI MECHAAL, Professor

Role: CONTACT

72100533 ext. 00216

KTATA HIBA, Dr

Role: CONTACT

72100500 ext. 00216

Facility Contacts

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BEN ALI MECHAAL

Role: primary

53890987 ext. 00216

Other Identifiers

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UTEM ELKI

Identifier Type: -

Identifier Source: org_study_id

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