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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

Tracking Information
First Submitted Date  ICMJE February 27, 2013
First Posted Date  ICMJE April 26, 2013
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
  • Pain scores [ Time Frame: pain scores from the PACU to the 3rd day after surgery ]
    From the PACU to the 3rd day after surgery
  • Morphine consumption [ Time Frame: From the PACU to the 3rd day after surgery ]
    Morphine consumption from the PACU to the 3rd day after surgery
  • Ileus time [ Time Frame: Day 1 and Day 3 after surgery ]
    time to get flattus after surgery
  • Surgical complications [ Time Frame: Within 3 days after surgery ]
    Infections, leakage, abcess
  • Fentanyl dose [ Time Frame: Operative time ]
    Cumulative dose of fentanyl needed for the surgery
  • 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
  • Major adverses events [ Time Frame: Start of the surgery untill one hour after PACU ad;ission ]
    Hypotension, heart rythm blocks, tachycarida, bradycardia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
Official Title  ICMJE NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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%
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Intravenous Lidocaine
  • Placebo Comparator: Placebo
    Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
    Intervention: Drug: Normal saline infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841294
Other Study ID Numbers  ICMJE 11077
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital
Study Sponsor  ICMJE Maisonneuve-Rosemont Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louis-Philippe Fortier, M.D. Hôpital Maisonneuve Rosemont
PRS Account Maisonneuve-Rosemont Hospital
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP