Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Tunis El Manar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe intraoperative complications.
Duration of surgery longer than 5 hours.
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine IV
DrugIntravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Ketamine Injectable Solution
DrugIntravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: IV-LidoExperimental treatment 1 intervention
Group B: IV-KetaActive comparator 1 intervention
Trial outcomes
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.
Time frame
24 hours after surgerySecondary outcomes
1
Pain assessed by Numerical Rating Scale (NRS)
Postoperative pain was assessed by the 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'.2
Post-operative nausea and vomiting
Incidence of post-operative nausea and vomiting during the first 24 hours.
Time frame
During the first 24 hours postoperatively3
Bowel function.
Time to return of bowel function.
Time frame
During the first 24 hours postoperatively4
Hospital length of stay.
Hospital length of stay ( in days)
Time frame
From date of randomization until the date of to discharge from the hospital assessed up to 15 daysSponsors and contacts
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Source ClinicalTrials.gov