Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001580272 Date of Approval: 11/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The influence of Isoflurane versus combined isoflurane - epidural anesthesia on the immune response in patients undergoing surgery for colorectal canc
Official scientific title The influence of Isoflurane versus combined isoflurane - epidural anesthesia on the immune response in patients undergoing surgery for colorectal cancer
Brief summary describing the background and objectives of the trial Surgical stress causes variable effects on haemodynamic and immunologic responses with the release of various stress hormones . Also, anaesthesia affects the immune response with the release of different cytokines which affect the inflammatory response in the postoperative period. Among the cytokines which affect these responses were the Tumour Necrosis Factor ¿ (TNF-¿), Interleukin-6 (IL-6) and Interleukin-10 (IL-10). Cytokines are intracellular regulatory proteins acting through specific receptors, and have a major role in the immune response and inflammatory changes caused by surgery or infection. There are two main groups of cytokines; proinflammatory cytokines produced by macrophages mainly acting through upregulation of inflammatory reactions and anti-inflammatory cytokines acting through the downregulation of inflammatory reactions. The balance between the proinflammatory cytokines (TNF-¿ and IL-6) and the anti-inflammatory cytokines (IL-10) limit the spread of infection, tissue injury and promote tissue healing and repair by their local and systemic effects (4-6). It has been shown that there are differences between intravenous and volatile anaesthetics in their effects on the immune response (7-8).Isoflurane and sevoflurane inhibit natural killer (NK) function to a greater degree than propofol. Aim of the study The aim of the present study was to compare the influence of anaesthesia using Isoflurane versus combined isoflurane - epidural anesthesia in patients undergoing surgery for colorectal cancer on immune response and plasma concentrations of pro- and anti-inflammatory interleukins IL-6 , IL-10 and TNF-¿.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/02/2016
Actual trial start date 13/02/2016
Anticipated date of last follow up 02/07/2016
Actual Last follow-up date 02/07/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group isoflurane group Anesthesia will be maintained by isoflurane (1%- 1.2%) throughout the surgical time patients of this group will receive balanced inhalational anesthesia by using isoflurane. 30
Experimental Group isoflurane-epidural group The solution for epidural analgesia will be consisted of bupivacaine 0.125% plus fentanyl 2¿g/ml. the infusion of solution for epidural analgesia will be started after induction of anesthesia and cont throughout the surgical time patients of this group will receive isoflurane anesthesia with intraoperative epidural analgesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
above the age of 18 years, ASA I-II undergoing elective undergoing elective surgical intervention for colorectal cancer 1- Emergency surgery 2- Renal dysfunction 3- Hepatic dysfunction 4- Cardiovascular diseases 5- Diabetes mellitus 6- Contraindications of epidural analgesia 7- Recent intake of corticosteroids or nonsteroidalantiinflammatory medications 8- Recent history of radiotherapy or chemotherapy 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/04/2016 Mansoura Faculty of Medicine, MFM-IRB
Ethics Committee Address
Street address City Postal code Country
Mansoura Mansoura Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome interleukins IL-6 , IL-10 before the start of anesthesia after 24 hours from anesthesia
Secondary Outcome TNF¿ before the start of anesthesia after 24 hours from anesthesia
Secondary Outcome postoperative complication (nausea and vomiting, respiratory depression, hypotension and bradycardia) postoperative
Secondary Outcome hospital stay postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals Algeish Tanta 31512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source for funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed M Abu Elyazed Algeish Tanta 31512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed M Abu Elyazed algeish Tanta 31512 Egypt
Ahmed Essam Eldin algeish Tanta 31512 Egypt
Maysaa Elsayed Zaki Mansoura Mansoura Egypt
Maha Mahmoud Hagras algeish Tanta 31512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abu Elyazed mohd_yazed75@yahoo.com oo20403462350 algeish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Public Enquiries Ahmed Essam Eldin madamada6@gmail.com 00201001802978 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abu Elyazed mohd_yazed75@yahoo.com +20403462350 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
REPORTING
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