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Trial record 49 of 318 for:    colon cancer | ( Map: Canada )

NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01841294
Recruitment Status : Unknown
Verified January 2012 by Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital

Brief Summary:

Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.

A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.

Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.

The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Intravenous Lidocaine Drug: Normal saline infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous Lidocaine
Patients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission
Drug: Intravenous Lidocaine
Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Other Name: Chlorydrate de Lidocaine 2%

Placebo Comparator: Placebo
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
Drug: Normal saline infusion
Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h




Primary Outcome Measures :
  1. Dosage of NKs activity after surgery [ Time Frame: compare the activity of NK cells on day 1 and day 3 after surgery ]
    Dosage of NKs activity after surgery


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: pain scores from the PACU to the 3rd day after surgery ]
    From the PACU to the 3rd day after surgery

  2. Morphine consumption [ Time Frame: From the PACU to the 3rd day after surgery ]
    Morphine consumption from the PACU to the 3rd day after surgery

  3. Ileus time [ Time Frame: Day 1 and Day 3 after surgery ]
    time to get flattus after surgery

  4. Surgical complications [ Time Frame: Within 3 days after surgery ]
    Infections, leakage, abcess

  5. Fentanyl dose [ Time Frame: Operative time ]
    Cumulative dose of fentanyl needed for the surgery

  6. Nausea and vomiting [ Time Frame: From the PACU to the 3rd day after surgery ]
    Nausea and vomiting from the PACU to the 3rd day after surgery

  7. Major adverses events [ Time Frame: Start of the surgery untill one hour after PACU ad;ission ]
    Hypotension, heart rythm blocks, tachycarida, bradycardia



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted for resection of colorectal cancer under laparoscopic surgery
  • American Society of Anesthesiologists class I-III.
  • The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.

Exclusion Criteria:

  • Subjects allergic to any of the study drugs.
  • BMI > 35 kg/m2.
  • Severe renal or hepatic failure.
  • Pregnancy.
  • Emergent procedure.
  • Heart failure NYHA > III.
  • Systolic blood pressure < 90 mmHg.
  • Advanced heart block (unless patient has a pacemaker).
  • Unstable angina and/or myocardial infarction within past 6 weeks.
  • FEV1 ≤ 0.8 L.
  • Oxygen-dependent patient.
  • Electrocardiographic abnormalities
  • Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic
  • Morphine intolerance or allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841294


Contacts
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Contact: louis-Philippe Fortier, M.D. 1 514 252 3400 fortierlp@mac.com

Locations
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Canada, Quebec
Hôpital Maisonneuve Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Nadia godin    1 514 252 3400 ext 3153    ngodin.hmr@ssss.gouv.qc.ca   
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Louis-Philippe Fortier, M.D. Hôpital Maisonneuve Rosemont

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Responsible Party: Louis-Philippe Fortier, Principal investigator, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01841294     History of Changes
Other Study ID Numbers: 11077
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: January 2012
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action