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NCT Number: NCT05448586

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

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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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opioid

Drug

Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery

Other names: Opioid Free Anesthesia

Primary outcomes

  1. Postoperative Systemic Inflammatory Response (C-Reactive Protein)

    Time frame: 48 hours after surgery

    To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level

  2. Postoperative Systemic Inflammatory Response (Leucocytes Ratio)

    Time frame: 48 hours after surgery

    To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio

  3. Postoperative Systemic Inflammatory Response (Platelet Level)

    Time frame: 48 hours after surgery

    To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level

Secondary outcomes

  1. Time spent in the Post-Anesthesia Care Unit (PACU)

    Time frame: 30 days after surgery

    To compare recovery time between groups

  2. Hospital stay

    Time frame: 30 days after surgery

    To compare hospital stay in both groups

  3. Rate of later postoperative complications

    Time frame: 3 months after surgery

    Complications due to surgery which required hospitalization

  4. Number of Participants with Cancer recurrence after surgery

    Time frame: 12 months after surgery

    To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups.

  5. Number of patients who Survive 12 months after surgery

    Time frame: 12 months after surgery

    To compare cancer survival 12 months after surgical treatment between groups

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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