NCT05448586

Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?

Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: Female
• Age: 20 Years – 91 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cervix Cancer
• Endometrial Cancer
• Ovarian Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Opioid	Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery

Timeline

• Start date: 2019-02-02
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2022-07-07
• Last updated: 2022-07-07

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study