Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272461
• Other study ID #: UTEM ELKI
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University Tunis El Manar
• Contact: BEN ALI MECHAAL, Professor
• Phone: 72100533
• Email: mechaal_benali[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal (Colon or Rectal) Cancer
• Inflammation

Intervention

Drug:
• Lidocaine IV
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
• Ketamine Injectable Solution
Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer

Locations

Country	Name	City	State
Tunisia	Tunisia	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

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