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.: PACTR202102898053019 Date of Approval: 24/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Propofol based TIVA versus inhalational anesthesia and colorectal cancer recurrence, a prospective randomized study
Official scientific title Propofol based total intravenous anesthesia versus inhalational anesthesia and colorectal cancer recurrence, a prospective randomized study
Brief summary describing the background and objectives of the trial Recent evidence have emerged which suggests that handling of tumor and the stress response to surgery may promote haematogenous cancer dissemination and alter the immune response to the disseminated cancer cells[1–3]. Perioperative factors such as anesthesia, analgesia, blood transfusion and temperature control could all interact with and impact on the surgical outcome. Among them, one of the main modifiable factors in anesthesia is the choice of volatile anesthetics or intravenous anesthetic for the maintenance of general anesthesia[4,5]. While total intravenous anesthesia (TIVA) with propofol has a slightly higher risk of intraoperative awareness and intraoperative hypotension, it also allows for faster emergence, reduced risk of postoperative nausea and vomiting[6,7]. In addition, more recent studies suggest that propofol may have some anti-tumor properties. In contrast, volatile anesthetics (VA) such as isoflurane and sevoflurane have been reported to promote the proliferation and migration of various cancer cell lines in vitro, and increase the tumor load in vivo. It therefore stands to reason that propofol TIVA may reduce cancer cell dissemination during surgery, reduce cancer recurrence and increase patient survival. In the past few years, several studies have compared long-term outcomes of patients operated with inhalational anesthesia and TIVA and reported varying degrees of success with TIVA[8–10]. This prospective randomised study aims to evaluate the effect of propofol bases TIVA on cancer patent outcome after colorectal surgeries regarding the tumor free survival, 1-year survival, cancer recurrence.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TIVA in colorectal cancer
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/03/2021
Actual trial start date
Anticipated date of last follow up 10/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R.21.01.1166 Institutional Research Board-Mansoura university
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group I group Patients will be followed up for 1 year after surgery Standard monitoring will be used. Patients will receive fentanyl 2 micro gram/kg IV 2 min prior to induction of anesthesia. In most instances, after loss of eyelash reflex, Atracrium 0.5 mg/kg IV will be given prior to tracheal intubation. After preoxygenation, anesthesia will be induced by mask with sevoflurane starting at 0.5% and incrementally increased to 3.5%-4.0% inhaled concentration at a total gas flow of 6 L in group I patients. 100 Active-Treatment of Control Group
Experimental Group Group T Patients will be followed up for 1 year In Group T, patients will receive propofol 1.5-2.0 mg/kg IV for induction of anesthesia. Maintenance anesthesia consisted of the primary anesthetic, along with 0.4 oxygen/air mixtures at a total gas flow of 2 L, titrated to maintain hemodynamic variables within 15% of pre-induction levels and BIS at 40 to 50. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with colorectal malignancy scheduled for surgery Patients with age less than 18 ASA classification more than 3 Metastatic tumor Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 25/01/2021 Institutional research board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1-year cancer free survival 1 year after surgery
Secondary Outcome 1-year survival 1 year after surgery
Secondary Outcome postoperative metastasis 1 year after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospitals Geihan street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoreya street MAnsoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Maoataz Emara Geihan street Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alreafey Alreafey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes planning to share the study protocol, summary results table within 6 month after completion of the research Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 month after trial completion Researchers or groups covered by an approved ethical board
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information