Anesthesia and Postoperative Outcome in Colorectal Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02786329|
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: TIVA+lidocaine Drug: Sevoflurane+lidocaine Drug: TIVA+placebo Drug: Sevoflurane+placebo||Early Phase 1|
- Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
- Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.
- Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
- Evaluation of the influence of lidocaine on postoperative inflammatory response
- Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Active Comparator: TIVA + lidocaine
TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion.
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Other Name: TIVA-L
Placebo Comparator: TIVA+placebo
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Other Name: TIVA-P
Placebo Comparator: Sevoflurane+placebo
Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo).
Intervention: sevoflurane anesthesia +placebo (saline infusion)
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Other Name: Sevo-P
Active Comparator: Sevoflurane+lidocaine
Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively.
Intervention: sevoflurane anesthesia+ lidocaine infusion
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Other Name: Sevo-L
- Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer [ Time Frame: 5 years ]
- Incidence of recurrences: [ Time Frame: 5 years ]
- Morphine consumption during the first 24 postoperative hours [ Time Frame: 0- 24 h ]
- Severity of postoperative pain - verbal response pain (VRPS) score in recovery room and during the first 48 hrs postoperatively [ Time Frame: 0- 48 h ]
- Resumption of bowel function [ Time Frame: 0-72 h ]
- Length of hospital stay [ Time Frame: 0-10 days ]
- Postoperative chronic pain [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786329
|Contact: Daniela IONESCU, Profemail@example.com|
|Contact: Caius Breazu, Assist Proffirstname.lastname@example.org|
|Clinica ATI, str Croitorilor nr 19-21||Recruiting|
|Cluj-napoca, Cluj, Romania, 400162|
|Contact: Daniela Ionescu, Prof +40744771209 email@example.com|
|Contact: Caius Breazu, Assit Prof +40743010012 firstname.lastname@example.org|
|Principal Investigator: Tiberiu Tat, PhD student|
|Institutul Oncologic Prof Dr Ion Chiricuta||Recruiting|
|Cluj-Napoca, Cluj, Romania|
|Contact: Tiberiu Tat, doctor email@example.com|
|Principal Investigator:||Daniela Ionescu, Prof||Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca|