Anesthesia and Postoperative Outcome in Colorectal Cancer Patients
The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients
1 other identifier
interventional
450
1 country
2
Brief Summary
Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery. As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered. Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 colorectal-cancer
Started Jun 2016
Longer than P75 for early_phase_1 colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 20, 2022
January 1, 2022
6.2 years
May 23, 2016
January 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
Survival at 5 years will be recorded
5 years
Incidence of recurrences:
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.
5 years
Secondary Outcomes (8)
Morphine consumption during the first 24 postoperative hours
0- 24 h
Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3
0- 48 h
Resumption of bowel function
0-72 h
Length of hospital stay
0-10 days
Postoperative chronic pain
1 year
- +3 more secondary outcomes
Other Outcomes (1)
Rate of local anaesthetics systemic toxicity incidence
0-48 hours
Study Arms (4)
TIVA + lidocaine
ACTIVE COMPARATORTIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine
TIVA+placebo
PLACEBO COMPARATORTIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
Sevoflurane+placebo
PLACEBO COMPARATORSevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)
Sevoflurane+lidocaine
ACTIVE COMPARATORSevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion
Interventions
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Eligibility Criteria
You may qualify if:
- Elective surgery
You may not qualify if:
- persistent chronic pain
- chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- Contraindications for any of the study medications
- Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
- Significant hepatic (ALAT and/or ASAT \> 2 normal values) or renal (plasma creatinine \> 2 mg/dl) disorders
- Convulsive disorders requiring medication during the last 2 years
- Planned regional analgesia/anesthesia (spinal or epidural)
- Corticoid dependent asthma
- Autoimmune disorders
- Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
- Refusal for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinica ATI, str Croitorilor nr 19-21
Cluj-Napoca, Cluj, 400162, Romania
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Related Publications (9)
Fodale V, D'Arrigo MG, Triolo S, Mondello S, La Torre D. Anesthetic techniques and cancer recurrence after surgery. ScientificWorldJournal. 2014 Feb 6;2014:328513. doi: 10.1155/2014/328513. eCollection 2014.
PMID: 24683330BACKGROUNDHeaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
PMID: 23242747BACKGROUNDMao L, Lin S, Lin J. The effects of anesthetics on tumor progression. Int J Physiol Pathophysiol Pharmacol. 2013;5(1):1-10. Epub 2013 Mar 8.
PMID: 23525301BACKGROUNDCakmakkaya OS, Kolodzie K, Apfel CC, Pace NL. Anaesthetic techniques for risk of malignant tumour recurrence. Cochrane Database Syst Rev. 2014 Nov 7;2014(11):CD008877. doi: 10.1002/14651858.CD008877.pub2.
PMID: 25379840BACKGROUNDCassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
PMID: 25769963BACKGROUNDDivatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.
PMID: 24803747BACKGROUNDKaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PMID: 17197840RESULTMcCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
PMID: 20518581RESULTAlexa AL, Tat TF, Ionescu D. The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study. Trials. 2022 Mar 18;23(1):219. doi: 10.1186/s13063-022-06157-4.
PMID: 35303929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Ionescu, Prof
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
- PRINCIPAL INVESTIGATOR
Alexandru Alexa, Assist Prof
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2016
First Posted
June 1, 2016
Study Start
June 1, 2016
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
January 20, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be shared between cooperation institutions every 3 month and whenever necessary.
- Access Criteria
- Access criteria are: active involvement into the study, the need to register data into the common database. The need to report data into the PhD thesis is also an access criteria.
Regular meeting for sharing data.