Anesthetic Technique on Immune Response in Colorectal Cancer

NCT01902849 | Completed

• 1 other identifier: TICC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Neoplasms

Keywords

intravenous anesthesia; inhalational anesthesia; interleukins; colorectal surgery

Outcome Measures

Primary Outcomes (4)

• measurement of interleukins IL6 and IL 10 plasmatic level

  -once the intravenous cannula is inserted

  -before anesthesia induction (T0 time)

• measurement of interleukins IL6, IL10 plasmatic level

  * 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 %

  after anesthesia induction but before surgical incision (T1)

• measurement of interleukins IL6 and IL10 plasmatic level

  2 hours postoperatively (T2)

• measurement of interleukins IL6 and IL 10 plasmatic level

  24 hours postoperatively (T3)

Secondary Outcomes (1)

• total opioid analgesic dose (mg)

  for the first 24 hours postoperatively

Other Outcomes (3)

• Pain score on the visual analog scale (VAS 0-10)

  for the first 24 hour postoperatively

• incidence of postoperative nausea and vomiting episodes requiring antiemetic medication

  for the 24 hours postoperatively

• total opioid dose of remifentanil (mg ) used during surgery

  an average 3 hours

Study Arms (2)

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

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

Interventions

blood sampling for IL measurement OTHER

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 1 - TIVA-TCI; Group II- ISOFLURANE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patient with colorectal neoplasms

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy Iuliu Hatieganu; Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor

Cluj-Napoca, 400162, Romania

Location

Related Publications (2)

• Ke JJ, Zhan J, Feng XB, Wu Y, Rao Y, Wang YL. A comparison of the effect of total intravenous anaesthesia with propofol and remifentanil and inhalational anaesthesia with isoflurane on the release of pro- and anti-inflammatory cytokines in patients undergoing open cholecystectomy. Anaesth Intensive Care. 2008 Jan;36(1):74-8. doi: 10.1177/0310057X0803600113.

  PMID: 18326136 BACKGROUND

• Margarit SC, Vasian HN, Balla E, Vesa S, Ionescu DC. The influence of total intravenous anaesthesia and isoflurane anaesthesia on plasma interleukin-6 and interleukin-10 concentrations after colorectal surgery for cancer: a randomised controlled trial. Eur J Anaesthesiol. 2014 Dec;31(12):678-84. doi: 10.1097/EJA.0000000000000057.

  PMID: 24614619 DERIVED

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 °

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Simona C Margarit, lecturer

  University of Medicine and Pharmacy Iuliu Hatieganu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior lecturer, consultant in anesthesia and intensive care

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: July 18, 2013
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

RO (1)