Effect of SmtO2 Guided Care on PONV (iMODIPONV)
Condition: Postoperative Nausea and Vomiting; Hysterectomy; Tissue Oxygenation; Cardiac Output Management; Blood Pressure Management
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This randomized controlled trial is to investigate if SmtO2-guided management on top of the
      usual care, compared with the usual care only, during laparoscopic hysterectomy significantly
      reduces the incidence of PONV.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) remains prevalent despite the institution of various
      prophylactic measures. The incidence of PONV in female patients undergoing laparoscopic
      gynecological surgery is up to 50% with and 70% without the administration of antiemetics,
      respectively. The consequences of PONV range from patient discomforts, postoperative
      complications, prolonged hospitalization, to increased health care costs. Among the multiple
      risk factors, suboptimal gastrointestinal (GI) perfusion or oxygenation may be responsible
      for some cases of PONV; however, this speculation remains to be confirmed.5 Optimal tissue
      oxygenation, the balance between tissue oxygen consumption and supply, is essential for the
      integrity of any tissue bed that is metabolically active. However, GI oxygenation cannot be
      directly and continuously monitored in patients at this time. Whether there is an organ which
      can be used as a surrogate of the GI system, meaning that the tissue oxygenation of this
      surrogate organ not only can be monitored and that it also correlates with that of the GI
      system, is an intriguing question. Currently, tissue oxygenation can be measured using
      near-infrared spectroscopy (NIRS) in patients. The recent advancements of this technology
      enable the accurate monitoring of the oxygenation within many tissue beds depending on the
      location of the oximetry probe.

      The recent cohort study demonstrated that there is a close relationship between muscular
      tissue oxygen saturation (SmtO2) and PONV in patients undergoing robotic laparoscopic
      hysterectomy (manuscript accepted and in production). Multiple thresholds based on threshold,
      AUC, and multivariable analyses are able to differentiate the risk of PONV. The following
      SmtO2 thresholds were found to correlate with a reduced risk of PONV: 20% above baseline;
      while the following thresholds correlate with an increased risk of PONV: 5% below baseline,
      15% below baseline, and 20% below baseline, < 70%, < 65%, and < 60%. Taken together, our
      study suggests the potential therapeutic targets for PONV prophylaxis may be to maintain
      SmtO2 > 70% and above baseline.

      In this study, the investigators aim to investigate if intraoperative care guided by SmtO2
      monitoring reduces the incidence of PONV after laparoscopic hysterectomy.
    

Intervention name(s): Muscular tissue oxygen saturation guided care
Intervention type(s): Device
Intervention description(s): Muscular tissue oxygen saturation monitored at flank and arm will be maintained > 70% (absolute measurement) and > baseline throughout the entire procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: International, multi-center, pragmatic, randomized controlled (1:1 ratio) trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Nausea and Vomiting; Laparoscopic Hysterectomy; Muscular Tissue Oxygen Saturation; Hemodynamic Management