Breast Cancer, Cervix Cancer, Endometrial Cancer, Ovarian Cancer
Conditions
Keywords
Opioid, Opioid Free Anesthesia, SIRS (Systemic Inflammatory Response), Postoperative infection
Brief summary
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.
Detailed description
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
Interventions
DRUGOpioid
Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 91 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, both combined with regional anesthesia.
Exclusion criteria
* Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, but had later surgery with a different to previous anesthesia technique. * Patients who had no later follow up during 12 months in the same Hospital, so we cannot register recurrence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Systemic Inflammatory Response (C-Reactive Protein) | 48 hours after surgery | To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level |
| Postoperative Systemic Inflammatory Response (Leucocytes Ratio) | 48 hours after surgery | To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio |
| Postoperative Systemic Inflammatory Response (Platelet Level) | 48 hours after surgery | To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Cancer recurrence after surgery | 12 months after surgery | To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups. |
| Time spent in the Post-Anesthesia Care Unit (PACU) | 30 days after surgery | To compare recovery time between groups |
| Number of patients who Survive 12 months after surgery | 12 months after surgery | To compare cancer survival 12 months after surgical treatment between groups |
| Hospital stay | 30 days after surgery | To compare hospital stay in both groups |
| Rate of later postoperative complications | 3 months after surgery | Complications due to surgery which required hospitalization |
Countries
Spain
Outcome results
None listed