Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

Not Applicable

Recruiting

• Conditions: Colorectal (Colon or Rectal) Cancer; Inflammation
• Interventions: Drug: Ketamine Injectable Solution; Drug: Lidocaine IV

• Registration Number: NCT06272461
• Lead Sponsor: University Tunis El Manar

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.

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 Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV-Keta	Ketamine Injectable Solution	Intravenous Ketamine dose loading than continuous infusion
IV-Lido	Lidocaine IV	Intravenous Lidocaine dose loading than continuous infusion

Primary Outcome Measures

Name	Time	Method
The variation of Interleukin-6 levels	24 hours after surgery	The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
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'.	Postoperative pain was assessed by the Numerical Rating Scale (NRS)
Post-operative nausea and vomiting	During the first 24 hours postoperatively	Incidence of post-operative nausea and vomiting during the first 24 hours.
Bowel function.	During the first 24 hours postoperatively	Time to return of bowel function.
Hospital length of stay.	From date of randomization until the date of to discharge from the hospital assessed up to 15 days	Hospital length of stay ( in days)
Post-operative complications.	From date of randomization until the date of to discharge from the hospital assessed up to 15 days	Incidence of intrahospital post-operative complications.

Trial Locations

Locations (1)

Tunisia; 🇹🇳 Nabeul, Tunisia