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Anesthetic Technique on Immune Response in Colorectal Cancer (T-IL-Co-ReCa)

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ClinicalTrials.gov Identifier: NCT01902849
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Margarit Simona, Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary:
Knowing the fact that the anesthetic substances can alter the immune response during the surgery, the purpose of the study is to evaluate the influence of two general anesthetic techniques - inhalation vs. total intravenous anesthesia on the immune response in patient with colorectal surgery for neoplastic disease, evaluated by the plasma level of the interleukins 6 and 10(IL6, IL10).

Condition or disease Intervention/treatment
Colorectal Neoplasms Other: blood sampling for IL measurement

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Influence of Anesthetic Technique on Interleukin Plasma Level in Colorectal Cancer Surgery - TIVA vs Inhalation Anesthesia
Study Start Date : February 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 - TIVA-TCI
  • include 35 patients with colorectal cancer undergoing surgery
  • anaesthesia is induced and maintained with total intravenous target-controlled infusion ( TIVA-TCI) of propofol and remifentanil.
  • for propofol initial target plasma concentration (Cp) is set to 4 micrograms/ml (modified Marsh model)( Base Primea™, Fresenius, France) and then adjusted in steps 0.2 micrograms/ml to maintain the BIS values between 40-55 during surgery.
  • for Remifentanil initial Cp is set at induction at 4 ng/ml and then the Cp is maintained between 3-8 ng/mL(increments of 0.5 ng/ml in case of inadequate anesthesia).
  • intervention:blood sampling for IL measurement
Other: blood sampling for IL measurement

Blood sampling to determine interleukins IL6 , IL10 plasma levels are drawn at the following moments:

  • T0- before the induction of anesthesia (venous cannula insertion time)
  • T1- after induction but before starting surgery

    • In the group I (TIVA -TCI) when the plasma concentration of propofol is 3-3.5 ng/ml
    • In group II (ISOFLURANE) when concentration of isoflurane in exhaled air (Et Isoflurane) is between 0.3-0.5%
  • T2, T3- at 2 and 24 hours after surgery

Group II- ISOFLURANE
  • include 35 patients with colorectal cancer undergoing surgery
  • anesthesia is induced with propofol bolus 1,5-2 mg/kg and remifentanil TCI mode (Minto model) (Base Primea™, Fresenius, France) with an initial Cp 4 ng/ml
  • maintenance of anesthesia is achieved with isoflurane 1-1.5 MAC in order to maintain the BIS value between the values of 40-55 and remifentanil TCI with Cp between 3-8 ng/mL (increments of 0.5 ng/ml in case of inadequate anesthesia)
  • intervention:blood sampling for IL measurement
Other: blood sampling for IL measurement

Blood sampling to determine interleukins IL6 , IL10 plasma levels are drawn at the following moments:

  • T0- before the induction of anesthesia (venous cannula insertion time)
  • T1- after induction but before starting surgery

    • In the group I (TIVA -TCI) when the plasma concentration of propofol is 3-3.5 ng/ml
    • In group II (ISOFLURANE) when concentration of isoflurane in exhaled air (Et Isoflurane) is between 0.3-0.5%
  • T2, T3- at 2 and 24 hours after surgery




Primary Outcome Measures :
  1. measurement of interleukins IL6 and IL 10 plasmatic level [ Time Frame: -before anesthesia induction (T0 time) ]
    -once the intravenous cannula is inserted

  2. measurement of interleukins IL6, IL10 plasmatic level [ Time Frame: after anesthesia induction but before surgical incision (T1) ]
    • in group I (TIVA-TCI) when plasma concentration of propofol is 3-3.5 micrograms/ml
    • in group II (ISOFLURANE) when concentration of isoflurane in exhaled gases (Et iso) is between 0.3-0.5 %

  3. measurement of interleukins IL6 and IL10 plasmatic level [ Time Frame: 2 hours postoperatively (T2) ]
  4. measurement of interleukins IL6 and IL 10 plasmatic level [ Time Frame: 24 hours postoperatively (T3) ]

Secondary Outcome Measures :
  1. total opioid analgesic dose (mg) [ Time Frame: for the first 24 hours postoperatively ]

Other Outcome Measures:
  1. Pain score on the visual analog scale (VAS 0-10) [ Time Frame: for the first 24 hour postoperatively ]
    at 15, 30 minutes post surgery 6, 12, 18, 24 hours postoperatively

  2. incidence of postoperative nausea and vomiting episodes requiring antiemetic medication [ Time Frame: for the 24 hours postoperatively ]
  3. total opioid dose of remifentanil (mg ) used during surgery [ Time Frame: an average 3 hours ]
    total dose (mg) of remifentanil administered in TCI mode during surgery


Biospecimen Retention:   Samples Without DNA
The collected blood samples are centrifuged at 2500 rpm / min for 10 minutes and the resulting plasma is stored at -70 °


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with colorectal neoplasms
Criteria

Inclusion Criteria:

  • patients over 18 years with ASA physical status I-III.
  • colorectal cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
  • surgery performed by the same surgical team

Exclusion Criteria:

  • ASA physical status IV patients
  • hepatic and renal impairment
  • diabetes or other endocrine disorders
  • obesity (BMI 30 kg/m2)
  • immune disorders or immunosuppressive therapy
  • steroid treatment in the last 6 months
  • asthma

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): NCT01902849


Locations
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Romania
University of Medicine and Pharmacy Iuliu Hatieganu; Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor
Cluj Napoca, Romania, 400162
Sponsors and Collaborators
Iuliu Hatieganu University of Medicine and Pharmacy
Investigators
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Principal Investigator: Simona C Margarit, lecturer University of Medicine and Pharmacy Iuliu Hatieganu

Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margarit Simona, senior lecturer, consultant in anesthesia and intensive care, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT01902849     History of Changes
Other Study ID Numbers: TICC
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Margarit Simona, Iuliu Hatieganu University of Medicine and Pharmacy:
intravenous anesthesia
inhalational anesthesia
interleukins
colorectal surgery

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anesthetics
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation