Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced anesthesia with opioids | Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under balanced anesthesia including opioids between February 2019 and 2020 in Hospital La Paz. |
| |
| Opioid Free Anesthesia (OFA) | Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under Opioid Free anesthesia between February 2019 and 2020 in Hospital La Paz. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid | Drug | Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Systemic Inflammatory Response (C-Reactive Protein) | To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level | 48 hours after surgery |
| Postoperative Systemic Inflammatory Response (Leucocytes Ratio) | To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio | 48 hours after surgery |
| Postoperative Systemic Inflammatory Response (Platelet Level) | To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in the Post-Anesthesia Care Unit (PACU) | To compare recovery time between groups | 30 days after surgery |
| Hospital stay | To compare hospital stay in both groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
patients who Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer)
132 women, aged 20-91 years old and ASA I-IV, 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. They had surgery between February 2019 and February 2020 in Hospital La Paz de Madrid.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Brogly, PhD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julia Albano Polo | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28894976 | Background | Dubowitz JA, Sloan EK, Riedel BJ. Implicating anaesthesia and the perioperative period in cancer recurrence and metastasis. Clin Exp Metastasis. 2018 Apr;35(4):347-358. doi: 10.1007/s10585-017-9862-x. Epub 2017 Sep 11. | |
| 31298153 | Result | Malo-Manso A, Raigon-Ponferrada A, Diaz-Crespo J, Escalona-Belmonte JJ, Cruz-Manas J, Guerrero-Orriach JL. Opioid Free Anaesthesia and Cancer. Curr Pharm Des. 2019;25(28):3011-3019. doi: 10.2174/1381612825666190705183754. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days after surgery |
| Rate of later postoperative complications | Complications due to surgery which required hospitalization | 3 months after surgery |
| Number of Participants with Cancer recurrence after surgery | To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups. | 12 months after surgery |
| Number of patients who Survive 12 months after surgery | To compare cancer survival 12 months after surgical treatment between groups | 12 months after surgery |
| 28922235 | Result | Rossaint J, Zarbock A. Perioperative Inflammation and Its Modulation by Anesthetics. Anesth Analg. 2018 Mar;126(3):1058-1067. doi: 10.1213/ANE.0000000000002484. |
| 26497721 | Result | Byrne K, Levins KJ, Buggy DJ. Can anesthetic-analgesic technique during primary cancer surgery affect recurrence or metastasis? Can J Anaesth. 2016 Feb;63(2):184-92. doi: 10.1007/s12630-015-0523-8. |
| 30252709 | Result | Brown EN, Pavone KJ, Naranjo M. Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |