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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV-Lido | Experimental | Intravenous Lidocaine dose loading than continuous infusion |
|
| IV-Keta | Active Comparator | Intravenous Ketamine dose loading than continuous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine IV | Drug | Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. |
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INCLUSION CRITERIA:
NON INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BEN ALI MECHAAL, Professor | Contact | 72100533 | 00216 | mechaal_benali@yahoo.fr |
| KTATA HIBA, Dr | Contact | 72100500 | 00216 | Hibetallah.ktata@fmt.utm.tn |
| Name | Affiliation | Role |
|---|---|---|
| BEN ALI MECHAAL, Professor | university manar Tunis, Tunisia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tunisia | Recruiting | Nabeul | 8000 | Tunisia |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Intravenous Lidocaine vs intravenous ketamine
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| Ketamine Injectable Solution | Drug | Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer |
|
| Post-operative nausea and vomiting |
Incidence of post-operative nausea and vomiting during the first 24 hours. |
| During the first 24 hours postoperatively |
| Bowel function. | Time to return of bowel function. | During the first 24 hours postoperatively |
| 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 |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |