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NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intravenous Lidocaine
Normal saline infusion
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Maisonneuve RosemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous Lidocaine

Placebo

Arm Description

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

Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission

Outcomes

Primary Outcome Measures

Dosage of NKs activity after surgery
Dosage of NKs activity after surgery

Secondary Outcome Measures

Pain scores
From the PACU to the 3rd day after surgery
Morphine consumption
Morphine consumption from the PACU to the 3rd day after surgery
Ileus time
time to get flattus after surgery
Surgical complications
Infections, leakage, abcess
Fentanyl dose
Cumulative dose of fentanyl needed for the surgery
Nausea and vomiting
Nausea and vomiting from the PACU to the 3rd day after surgery
Major adverses events
Hypotension, heart rythm blocks, tachycarida, bradycardia

Full Information

First Posted
February 27, 2013
Last Updated
April 25, 2013
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01841294
Brief Title
NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
Official Title
NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Lidocaine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
Intervention Type
Drug
Intervention Name(s)
Intravenous Lidocaine
Other Intervention Name(s)
Chlorydrate de Lidocaine 2%
Intervention Description
Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Normal saline infusion
Intervention Description
Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Primary Outcome Measure Information:
Title
Dosage of NKs activity after surgery
Description
Dosage of NKs activity after surgery
Time Frame
compare the activity of NK cells on day 1 and day 3 after surgery
Secondary Outcome Measure Information:
Title
Pain scores
Description
From the PACU to the 3rd day after surgery
Time Frame
pain scores from the PACU to the 3rd day after surgery
Title
Morphine consumption
Description
Morphine consumption from the PACU to the 3rd day after surgery
Time Frame
From the PACU to the 3rd day after surgery
Title
Ileus time
Description
time to get flattus after surgery
Time Frame
Day 1 and Day 3 after surgery
Title
Surgical complications
Description
Infections, leakage, abcess
Time Frame
Within 3 days after surgery
Title
Fentanyl dose
Description
Cumulative dose of fentanyl needed for the surgery
Time Frame
Operative time
Title
Nausea and vomiting
Description
Nausea and vomiting from the PACU to the 3rd day after surgery
Time Frame
From the PACU to the 3rd day after surgery
Title
Major adverses events
Description
Hypotension, heart rythm blocks, tachycarida, bradycardia
Time Frame
Start of the surgery untill one hour after PACU ad;ission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
louis-Philippe Fortier, M.D.
Phone
1 514 252 3400
Email
fortierlp@mac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Fortier, M.D.
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia godin
Phone
1 514 252 3400
Ext
3153
Email
ngodin.hmr@ssss.gouv.qc.ca

12. IPD Sharing Statement

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NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

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