Julia Albano Polo
Madrid, 28046, Spain
NCT Number: NCT05448586
Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro influence on immunologic and inflammatory response, as well as in metastatic progression. For these reasons we believe that OFA may positively influence in oncologic patients postoperative recovery and in its disease progression.
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Notify Me20 year–91 year
Female
Observational
Madrid, 28046, Spain
After Local Ethics Committee approval, consecutive consenting patients scheduled for major gynecologic oncologic surgery were included between February 2019 and January 2020 in this observational retrospective study. We Compared OFA to standard technique used in our institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS), hospital stay, postoperative complications in the following 2 months, cancer progression and mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with 0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in both groups received a regional block when possible, dexamethasone 8 mg at induction and paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by Chi-square test. Statistical significance was set at p < 0.05
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery
Other names: Opioid Free Anesthesia
Time frame: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level
Time frame: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio
Time frame: 48 hours after surgery
To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level
Time frame: 30 days after surgery
To compare recovery time between groups
Time frame: 30 days after surgery
To compare hospital stay in both groups
Time frame: 3 months after surgery
Complications due to surgery which required hospitalization
Time frame: 12 months after surgery
To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups.
Time frame: 12 months after surgery
To compare cancer survival 12 months after surgical treatment between groups
Instituto de Investigación Hospital Universitario La Paz
Other
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study
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