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| Name | Class |
|---|---|
| Prof. Dr. I. Chiricuta Institute of Oncology | OTHER |
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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.
Main goals
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA + lidocaine | Active Comparator | TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine |
|
| TIVA+placebo | Placebo Comparator | TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion) |
|
| Sevoflurane+placebo | Placebo Comparator | Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion) |
|
| Sevoflurane+lidocaine | Active Comparator | Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA+lidocaine | Drug | Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption during the first 24 postoperative hours | Total morphine consumption during the first 24h after surgery will be recorded | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of local anaesthetics systemic toxicity incidence | An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient | 0-48 hours |
Inclusion Criteria:
Exclusion Criteria:
• persistent chronic pain
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela IONESCU, Prof | Contact | +40744771209 | dionescuati@yahoo.com | |
| Alexandru Alexa, Assist Prof | Contact | +40752691911 | alexandru_reziati@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica ATI, str Croitorilor nr 19-21 | Recruiting | Cluj-Napoca | Cluj | 400162 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24683330 | Background | 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. | |
| 23242747 | Background | Heaney 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. |
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Regular meeting for sharing data.
Data will be shared between cooperation institutions every 3 month and whenever necessary.
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.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| Sevoflurane+lidocaine | Drug | Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively. |
|
|
| TIVA+placebo | Drug | Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively |
|
|
| Sevoflurane+placebo | Drug | Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively |
|
|
The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively. |
| 0- 48 h |
| Resumption of bowel function | Time to first flatus will be registered and compared between groups. | 0-72 h |
| Length of hospital stay | LOS will be registered and compared between study groups. | 0-10 days |
| Postoperative chronic pain | Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview. Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice | 1 year |
| Postoperative imflamation | Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made. | Day 1 |
| Rate of postoperative complications after intravenous lidocaine infusion versus placebo | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia | 0-30 days |
| Rate of postoperative complications after TIVA versus inhalation anaesthesia | Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia | 0-30 days |
| Institutul Oncologic Prof Dr Ion Chiricuta | Recruiting | Cluj-Napoca | Cluj | Romania |
|
| 23525301 | Background | Mao 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. |
| 25379840 | Background | Cakmakkaya 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. |
| 25769963 | Background | Cassinello 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. |
| 24803747 | Background | Divatia 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. |
| 17197840 | Result | Kaba 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. |
| 20518581 | Result | McCarthy 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. |
| 35303929 | Derived | Alexa 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |